Author: admin

Understanding Compliance Training for 21 CFR Part 11

In the regulated environments of pharmaceutical, biotechnology, and medical device industries, compliance with government regulations is critical for maintaining product integrity, safety, and efficacy. One of the most important regulations that these industries must adhere to is 21 CFR Part 11, which establishes the criteria for electronic records and electronic signatures. This article explores the key aspects of compliance training for 21 CFR Part 11, its significance, and best practices for implementation.

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation set forth by the U.S. Food and Drug Administration (FDA) that governs the use of electronic records and electronic signatures in the production, clinical trials, and storage of data related to drugs, biologics, and medical devices. Introduced in 1997, Part 11 outlines the requirements for maintaining the integrity, security, and confidentiality of electronic records, as well as the authenticity of electronic signatures.

Key Components of 21 CFR Part 11

  1. Electronic Records: The regulation defines the criteria for when electronic records are considered equivalent to paper records. It emphasizes the importance of accuracy, reliability, and consistency in electronic documentation.
  2. Electronic Signatures: Part 11 stipulates that electronic signatures must be unique to the individual using them and must be verified through identity validation processes. These signatures must be linked to their respective records to ensure accountability.
  3. Audit Trails: Organizations must implement secure and time-stamped audit trails that record the creation, modification, and deletion of electronic records. This allows for tracking changes and verifying compliance.
  4. Security Controls: Adequate security measures must be in place to protect electronic records from unauthorized access, modification, or loss. This includes user access controls, data encryption, and regular system validations.
  5. Validation of Systems: Organizations are required to validate their electronic systems to ensure they meet all regulatory requirements. This process verifies that the system functions as intended and produces reliable results.
  6. Training and Procedures: Employees must be adequately trained on the use of electronic records and signatures, and organizations should have documented procedures to ensure compliance with Part 11.

Importance of Compliance Training for 21 CFR Part 11

1. Ensuring Data Integrity

Compliance training is crucial for ensuring the integrity of electronic records. Employees must understand the importance of accurate data entry, record-keeping practices, and the consequences of non-compliance. Training equips them with the knowledge to maintain high standards of data quality.

2. Minimizing Risks of Non-Compliance

Non-compliance with 21 CFR Part 11 can result in severe penalties, including fines, product recalls, and loss of market access. Comprehensive training reduces the risk of violations by ensuring that employees understand their responsibilities and the regulatory requirements.

3. Enhancing Organizational Reputation

A commitment to compliance training fosters a culture of integrity and accountability within an organization. Companies that prioritize compliance are viewed more favorably by regulatory agencies, partners, and customers, enhancing their reputation in the industry.

4. Facilitating Audit Readiness

Regular compliance training prepares employees for inspections and audits by regulatory agencies. A well-informed workforce can demonstrate adherence to regulations, making the audit process smoother and more efficient.

5. Promoting a Culture of Continuous Improvement

Training programs that include compliance components encourage ongoing learning and improvement. Employees who are educated on the importance of compliance are more likely to identify areas for enhancement in processes and systems.

Best Practices for Implementing Compliance Training

1. Develop a Comprehensive Training Program

A robust compliance training program should cover all aspects of 21 CFR Part 11. This includes the regulation’s requirements, the organization’s specific policies and procedures, and best practices for electronic record-keeping. The training should be tailored to various roles within the organization, ensuring that all employees understand their specific responsibilities.

2. Utilize Various Training Formats

Different employees may respond better to different training formats. A mix of e-learning modules, in-person workshops, and hands-on training can cater to various learning styles and enhance engagement. Incorporating real-world scenarios and case studies can help employees better understand the practical implications of compliance.

3. Ensure Accessibility and Flexibility

Training should be accessible to all employees, regardless of their location. Utilizing online platforms for training delivery allows for flexibility in scheduling and enables employees to revisit materials as needed. This is particularly important in organizations with multiple sites or remote workers.

4. Incorporate Assessments and Feedback

To evaluate the effectiveness of the training program, organizations should implement assessments to test employees’ understanding of the material. Providing opportunities for feedback can help identify areas for improvement and ensure that the training remains relevant and effective.

5. Maintain Documentation

Documenting training activities is essential for compliance with regulatory requirements. Organizations should maintain records of training completion, materials used, and any assessments administered. This documentation serves as evidence of compliance during audits and inspections.

6. Regularly Update Training Materials

The regulatory landscape is constantly evolving, and organizations must ensure their training materials reflect the most current guidelines and best practices. Regularly reviewing and updating training content helps maintain compliance and ensures employees are aware of any changes to regulations.

7. Foster a Culture of Compliance

Creating a culture that prioritizes compliance starts at the top. Leadership should demonstrate a commitment to regulatory adherence and provide ongoing support for training initiatives. Encouraging open communication about compliance-related concerns can empower employees to take ownership of their responsibilities.

8. Conduct Refresher Training

To reinforce the importance of compliance, organizations should implement refresher training sessions at regular intervals. This can help keep compliance top-of-mind for employees and ensure that knowledge remains current.

Challenges in Compliance Training for 21 CFR Part 11

1. Complexity of Regulations

The intricacies of 21 CFR Part 11 can pose challenges for organizations attempting to develop effective training programs. Navigating the regulation’s details requires expertise, and organizations may need to engage regulatory specialists to ensure accuracy.

2. Employee Engagement

Maintaining employee engagement in compliance training can be difficult, especially if employees view it as a tedious requirement. Incorporating interactive elements, gamification, and relevant examples can help make training more engaging and meaningful.

3. Resource Constraints

Developing and implementing a comprehensive training program requires time, financial resources, and expertise. Smaller organizations may struggle to allocate sufficient resources for compliance training, impacting the quality of the program.

4. Keeping Up with Changes

The regulatory landscape can change rapidly, and organizations must be prepared to adapt their training programs accordingly. Staying informed about updates to 21 CFR Part 11 and other relevant regulations is essential for ensuring ongoing compliance.

Conclusion

Compliance training for 21 CFR Part 11 is a fundamental aspect of ensuring data integrity, regulatory adherence, and organizational reputation in the pharmaceutical, biotechnology, and medical device industries. A well-designed training program equips employees with the knowledge and skills necessary to navigate the complexities of electronic records and signatures effectively.

By implementing best practices in compliance training—such as developing comprehensive programs, utilizing various formats, maintaining documentation, and fostering a culture of compliance—organizations can minimize the risks associated with non-compliance and enhance their overall operational effectiveness.

As regulatory requirements continue to evolve, ongoing training and education will be crucial in preparing organizations for the challenges ahead. Prioritizing compliance not only safeguards the organization against potential penalties but also contributes to a culture of integrity and accountability that can drive long-term success. In an increasingly digital world, understanding and adhering to 21 CFR Part 11 is more critical than ever, ensuring that the products reaching the market are safe, effective, and reliable.

Comprehensive Training on FDA 21 CFR Part 11:

In the realms of pharmaceuticals, biotechnology, and medical device manufacturing, regulatory compliance is not just a necessity; it is a critical component that ensures the integrity, safety, and efficacy of products. One of the key regulations that organizations must adhere to is the FDA’s 21 CFR Part 11, which outlines the requirements for electronic records and electronic signatures. Effective training on 21 CFR Part 11 is essential for employees at all levels of an organization to navigate these regulatory waters successfully. This article delves into the fundamentals of FDA 21 CFR Part 11 training, its importance, key components, implementation strategies, and best practices for ensuring compliance.

Understanding 21 CFR Part 11

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that governs the use of electronic records and electronic signatures in the context of submissions to the FDA. The regulation was introduced in 1997 to facilitate the use of electronic technology while ensuring that electronic records are trustworthy, reliable, and equivalent to traditional paper records.

Scope of 21 CFR Part 11

The regulation applies to all electronic records and signatures used in any activities governed by the FDA, including:

  • Clinical trials
  • Manufacturing processes
  • Laboratory testing
  • Quality assurance and control

Organizations must comply with Part 11 when they submit data to the FDA, ensuring that their electronic systems meet the necessary standards.

The Importance of Training on 21 CFR Part 11

1. Ensuring Data Integrity

The accuracy and reliability of electronic records are critical in regulated environments. Training on 21 CFR Part 11 equips employees with the knowledge they need to maintain data integrity, ensuring that all records are created, modified, and stored in compliance with the regulation.

2. Mitigating Compliance Risks

Non-compliance with 21 CFR Part 11 can result in severe consequences, including fines, product recalls, and even criminal charges. Comprehensive training helps employees understand the implications of non-compliance and empowers them to follow best practices, reducing the risk of violations.

3. Enhancing Audit Preparedness

Regulatory agencies like the FDA conduct routine audits to assess compliance. Well-trained employees can demonstrate adherence to 21 CFR Part 11, making the audit process smoother and minimizing the likelihood of penalties or adverse findings.

4. Fostering a Culture of Compliance

A strong training program promotes a culture of compliance within the organization. When employees understand the importance of regulatory adherence, they are more likely to take ownership of their responsibilities and contribute to a compliant work environment.

Key Components of FDA 21 CFR Part 11 Training

1. Overview of 21 CFR Part 11

Training should begin with a comprehensive overview of 21 CFR Part 11, including its purpose, scope, and key requirements. Employees should understand why the regulation exists and how it impacts their roles within the organization.

2. Electronic Records Management

Employees need to be trained on the proper management of electronic records, including:

  • Creation: Guidelines for creating accurate and reliable electronic records.
  • Maintenance: Procedures for storing, backing up, and protecting electronic records.
  • Retention: Understanding retention periods and proper disposal methods for electronic records.

3. Electronic Signatures

Training on electronic signatures is crucial for ensuring their integrity and security. Key topics should include:

  • Definition and equivalence to handwritten signatures.
  • Procedures for using electronic signatures in compliance with the regulation.
  • The importance of unique identification and identity verification.

4. Audit Trail Requirements

Employees must understand the significance of audit trails, which track changes made to electronic records. Training should cover:

  • What constitutes an audit trail and its components (time stamps, user identification, reasons for changes).
  • How to access and review audit trails for compliance monitoring.

5. Security Controls

To protect electronic records and signatures, training must address security measures, including:

  • Access controls: Who can access what information and how permissions are managed.
  • Data encryption: The importance of securing sensitive data during storage and transmission.
  • System validation: Understanding the need for validating electronic systems to ensure they meet regulatory requirements.

6. Organizational Policies and Procedures

Employees should be familiar with their organization’s specific policies and procedures related to 21 CFR Part 11. This includes:

  • Reporting non-compliance issues.
  • Documenting deviations and corrective actions.
  • Understanding roles and responsibilities in maintaining compliance.

7. Best Practices for Compliance

Training should also cover best practices for maintaining compliance with 21 CFR Part 11, such as:

  • Regular system checks and maintenance.
  • Ongoing education and training.
  • Staying updated on regulatory changes.

Implementing an Effective Training Program

1. Conduct a Training Needs Assessment

Before developing a training program, organizations should conduct a needs assessment to identify gaps in knowledge and skills related to 21 CFR Part 11. This assessment will inform the design of the training curriculum and ensure that it meets the specific needs of employees.

2. Develop Comprehensive Training Materials

Training materials should be well-structured, informative, and easy to understand. This may include:

  • Presentation slides outlining key concepts.
  • Handouts summarizing important points.
  • Interactive e-learning modules that allow for self-paced learning.

3. Utilize Various Training Formats

Different employees may have different learning preferences, so a mix of training formats can enhance engagement and retention. Consider incorporating:

  • In-person workshops for hands-on learning and discussion.
  • Online training modules for flexible, self-directed learning.
  • Simulation exercises to practice real-world applications of compliance.

4. Implement Assessments and Feedback

To evaluate the effectiveness of the training program, organizations should implement assessments that test employees’ understanding of 21 CFR Part 11. Feedback mechanisms, such as surveys and open discussions, can help identify areas for improvement in the training program.

5. Document Training Activities

Comprehensive documentation is essential for demonstrating compliance. Organizations should maintain records of training sessions, attendance, assessment results, and materials used. This documentation serves as evidence during regulatory audits and inspections.

6. Regularly Update Training Materials

As regulations evolve, so should training materials. Organizations should commit to reviewing and updating their training content regularly to ensure it remains current and relevant. This can be done in response to changes in 21 CFR Part 11 or organizational policies.

7. Foster a Supportive Learning Environment

Creating an environment that encourages ongoing learning and compliance is vital. Leaders should promote open communication about compliance issues and provide resources for employees to seek assistance when needed.

Challenges in FDA 21 CFR Part 11 Training

1. Complexity of the Regulation

The intricacies of 21 CFR Part 11 can pose challenges for trainers and employees alike. The technical language and extensive requirements may lead to confusion. Organizations may need to invest in expert trainers who can break down complex concepts into understandable terms.

2. Employee Resistance

Some employees may view compliance training as a burden or an additional task. Overcoming this resistance requires effective communication about the importance of the training and how it benefits both the organization and the employees.

3. Resource Limitations

Developing and implementing a comprehensive training program requires time, financial investment, and expertise. Smaller organizations may struggle to allocate the necessary resources, potentially impacting the quality of the training provided.

4. Keeping Up with Technological Advancements

The rapid pace of technological change can complicate compliance training efforts. Organizations must continuously assess their systems and ensure that their training reflects the most current tools and practices in electronic record management.

Best Practices for FDA 21 CFR Part 11 Training

1. Engage Leadership Support

Leadership support is crucial for the success of any training program. Executives should actively endorse compliance training and participate in sessions when possible, reinforcing its importance throughout the organization.

2. Tailor Training to Specific Roles

Different employees will have varying levels of interaction with electronic records and signatures. Tailoring training to specific roles within the organization ensures that each employee receives relevant information and training.

3. Promote Continuous Learning

Compliance training should not be a one-time event. Organizations should promote a culture of continuous learning by offering refresher courses, updates on regulatory changes, and opportunities for advanced training.

4. Leverage Technology

Utilizing technology for training can enhance engagement and accessibility. E-learning platforms can provide interactive modules, quizzes, and resources that employees can access anytime, allowing for flexibility in learning.

5. Monitor and Evaluate Training Effectiveness

Regularly monitoring and evaluating the effectiveness of the training program is essential. Organizations should analyze assessment results, employee feedback, and compliance metrics to identify areas for improvement and adjust the training program as needed.

Conclusion

Training on FDA 21 CFR Part 11 is vital for ensuring compliance in regulated industries. A well-designed training program equips employees with the knowledge and skills necessary to manage electronic records and signatures effectively, safeguarding data integrity and minimizing compliance risks.

By understanding the fundamentals of 21 CFR Part 11, organizations can foster a culture of compliance that not only meets regulatory requirements but also enhances operational efficiency and product safety. As the regulatory landscape continues to evolve, ongoing training and education will be essential in preparing organizations for the challenges ahead. In doing so, they will not only protect their interests but also contribute to public health and safety in the critical fields of pharmaceuticals and medical devices.

Fundamentals of 21 CFR Part 11: A Comprehensive Guide

In the highly regulated environments of pharmaceuticals, biotechnology, and medical devices, adherence to standards set forth by regulatory bodies is paramount. One of the critical regulations that organizations must comply with is 21 CFR Part 11, established by the U.S. Food and Drug Administration (FDA). This regulation addresses the use of electronic records and electronic signatures, laying out essential criteria for maintaining data integrity and ensuring compliance. This article will delve into the fundamentals of 21 CFR Part 11, discussing its significance, key components, implementation challenges, and best practices.

Understanding 21 CFR Part 11

What is 21 CFR Part 11?

21 CFR Part 11 is a federal regulation that specifies the FDA’s requirements for electronic records and electronic signatures. Established in 1997, the regulation was created to ensure that electronic documentation holds the same integrity, authenticity, and security as paper records. With the growing reliance on digital systems in clinical trials, laboratory practices, and manufacturing processes, 21 CFR Part 11 serves to protect the accuracy and confidentiality of critical data.

Scope of 21 CFR Part 11

The regulation applies to any organization that uses electronic records and signatures in connection with activities that fall under the jurisdiction of the FDA. This includes:

  • Pharmaceutical companies
  • Biotechnology firms
  • Medical device manufacturers
  • Contract research organizations (CROs)
  • Clinical laboratories

Organizations must comply with 21 CFR Part 11 when submitting data to the FDA, conducting clinical trials, and maintaining quality assurance.

Key Components of 21 CFR Part 11

1. Electronic Records

The regulation outlines that electronic records must be:

  • Accurate: All data entries must be correct and reflect the true state of affairs.
  • Reliable: The system used for electronic records must consistently produce accurate results.
  • Consistent: The integrity of electronic records must be maintained throughout their lifecycle.

To achieve these goals, organizations must implement controls to ensure that electronic records are stored securely, backed up regularly, and protected against unauthorized access or alterations.

2. Electronic Signatures

Part 11 defines electronic signatures as legally binding and equivalent to handwritten signatures. The regulation mandates that electronic signatures must meet specific criteria, including:

  • Unique Identification: Each electronic signature must be unique to the individual using it.
  • Identity Verification: Organizations must have procedures in place to verify the identity of individuals using electronic signatures.
  • Linking: Electronic signatures must be linked to their respective records in a way that ensures accountability and traceability.

These measures are crucial for maintaining the integrity of the signing process and ensuring that signatories are held accountable for their actions.

3. Audit Trails

Organizations are required to implement audit trails that record all changes made to electronic records. Audit trails must include:

  • Time Stamps: All entries and modifications must be time-stamped.
  • User Identification: The identity of the user making the change must be recorded.
  • Reason for Changes: A brief explanation of why changes were made should be included.

Audit trails provide a comprehensive history of records, allowing organizations to track modifications and ensure compliance during audits.

4. Security Controls

The regulation emphasizes the importance of security measures to protect electronic records and signatures. Key components include:

  • Access Controls: Only authorized personnel should have access to electronic records and signatures. User roles and permissions must be defined and managed.
  • Data Encryption: Sensitive information should be encrypted to prevent unauthorized access during storage and transmission.
  • Regular System Validation: Organizations must validate their electronic systems to ensure they meet all regulatory requirements and function as intended.

5. Validation of Systems

Organizations are required to validate any electronic systems used for creating, modifying, or storing electronic records. Validation involves:

  • Testing: Systems must be thoroughly tested to verify that they operate correctly and meet all user requirements.
  • Documentation: Comprehensive documentation of the validation process, including protocols and results, must be maintained.

Validation ensures that systems are reliable and capable of producing accurate and secure electronic records.

6. Training and Procedures

Employees must be adequately trained on the use of electronic records and signatures. This training should cover:

  • The significance of 21 CFR Part 11 and its requirements.
  • Procedures for using electronic systems.
  • Best practices for maintaining data integrity and security.

Documented procedures should outline the steps for creating, modifying, and storing electronic records and signatures, ensuring consistency and compliance across the organization.

Importance of 21 CFR Part 11 Compliance

1. Ensuring Data Integrity

Compliance with 21 CFR Part 11 is crucial for maintaining the integrity of electronic records. Accurate and reliable data is essential for making informed decisions in drug development, clinical trials, and quality assurance processes. Organizations that fail to maintain data integrity risk regulatory action, product recalls, and damage to their reputation.

2. Protecting Public Health

Regulatory compliance plays a significant role in protecting public health. By ensuring that electronic records are accurate and secure, organizations contribute to the development of safe and effective products. Non-compliance can lead to harmful consequences for patients and consumers.

3. Facilitating Audits and Inspections

Organizations that adhere to 21 CFR Part 11 are better prepared for regulatory audits and inspections. Well-documented processes, accurate records, and a robust training program help demonstrate compliance, reducing the risk of penalties or adverse findings during audits.

4. Enhancing Organizational Reputation

A commitment to compliance fosters a culture of integrity and accountability within an organization. Companies that prioritize regulatory adherence are viewed more favorably by regulatory agencies, partners, and customers, enhancing their overall reputation in the industry.

Challenges in Implementing 21 CFR Part 11 Compliance

1. Complexity of Regulations

The intricacies of 21 CFR Part 11 can pose challenges for organizations attempting to achieve compliance. The regulation’s technical language and extensive requirements may lead to confusion and misinterpretation. Organizations may need to consult regulatory experts to ensure they understand and implement the necessary controls effectively.

2. Resource Constraints

Implementing and maintaining compliance with 21 CFR Part 11 requires significant resources, including time, personnel, and financial investment. Smaller organizations may struggle to allocate sufficient resources, potentially impacting their ability to comply.

3. Keeping Up with Technology Changes

The rapid advancement of technology can complicate compliance efforts. Organizations must continuously assess their systems and processes to ensure they meet regulatory requirements while leveraging new technologies that can improve efficiency and data integrity.

4. Employee Training and Engagement

Ensuring that all employees understand their responsibilities under 21 CFR Part 11 is essential for compliance. However, training can be time-consuming and may face resistance from employees who view it as an additional burden. Organizations must develop engaging training programs to enhance understanding and commitment.

Best Practices for Achieving Compliance with 21 CFR Part 11

1. Develop a Compliance Strategy

Organizations should develop a comprehensive compliance strategy that outlines their approach to meeting the requirements of 21 CFR Part 11. This strategy should include a detailed plan for implementing controls, validating systems, and training employees.

2. Conduct Risk Assessments

Regular risk assessments can help organizations identify potential vulnerabilities in their electronic systems and processes. By proactively addressing these risks, organizations can strengthen their compliance posture and mitigate the likelihood of non-compliance.

3. Implement Robust Training Programs

A well-structured training program is essential for ensuring that employees understand the significance of 21 CFR Part 11 and their specific responsibilities. Training should be ongoing, incorporating updates on regulatory changes and best practices.

4. Maintain Comprehensive Documentation

Documentation is critical for demonstrating compliance with 21 CFR Part 11. Organizations should maintain detailed records of their procedures, training activities, validation efforts, and audit trails. This documentation will be invaluable during audits and inspections.

5. Regularly Review and Update Policies

Organizations should regularly review and update their policies and procedures to ensure they align with current regulatory requirements and best practices. This includes keeping abreast of any changes to 21 CFR Part 11 and adapting accordingly.

6. Foster a Culture of Compliance

Creating a culture that prioritizes compliance starts at the top. Leadership should demonstrate a commitment to regulatory adherence and support training initiatives, encouraging employees to take ownership of their responsibilities.

Conclusion

21 CFR Part 11 is a crucial regulation that governs the use of electronic records and signatures in the pharmaceutical, biotechnology, and medical device industries. Compliance with this regulation is essential for maintaining data integrity, protecting public health, and enhancing organizational reputation. While challenges exist in implementing compliance measures, organizations can achieve success through comprehensive training, robust documentation, and a commitment to ongoing improvement.

As the regulatory landscape continues to evolve, understanding the fundamentals of 21 CFR Part 11 and adhering to its requirements will be vital for organizations seeking to thrive in a competitive and highly regulated environment. By prioritizing compliance, organizations not only safeguard their operations but also contribute to the overall safety and efficacy of products that impact public health.

NYS attorney general probe finds NYC property owner guilty of discrimination

A NYC property owner and management company was hit with a hefty $400,000 punishment for illegally denying housing to potential renters in the Big Apple because of their sources of income, NYS Attorney General Letitia James announced Tuesday.

Shamco Management Corp., which owns or manages approximately 1,300 units, 1,161 of which are rent stabilized, in 31 buildings mostly located in Harlem and central Brooklyn, denied people access to housing because they had been given city vouchers designed to help low-income New Yorkers find homes, James’ office said.

Government-issued rental vouchers help low-income households with the ability to rent “decent, safe housing in the private market,” according to a press release from the attorney general. The vouchers, which include Section 8 housing, require participants to comply with all program requirements, which includes completing an annual certification.

James said Shamco violated New York’s human rights laws by refusing to rent to people who were using the vouchers to obtain housing, adding that the company intentionally ignored potential tenants once they revealed their voucher status.

Because it broke the law, Shamco will now pay $400,000 to potential renters who were denied housing because of their voucher status. The property group will also have to rent at least 65 units to tenants with housing subsidies and provide them with at least one renewal lease.

“Housing is a human right, and everyone deserves fair access to housing, regardless of their source of income,” James said. “Shamco’s discriminatory practices against voucher holders denied hardworking families the opportunity to secure stable housing and further exacerbated our housing crisis. My office will always stand up to ensure all New Yorkers are afforded equitable opportunities to find safe and affordable housing.”

Shamco did not return multiple requests for comment from amNewYork Metro.

The investigation into Shamco began in 2021 after the attorney general’s office uncovered several instances of discrimination, including refusing to show voucher holders rental units. The investigation also found that the company told a voucher holder that an apartment was already rented, though it was in fact available.

In another instance, one potential renter with cancer had a scheduled apartment tour with Shamco. But when he told the company he had a CityFHEPS voucher — a rental assistance supplement — the employee he had been working with stopped responding.

Additionally, according to the attorney general’s office, a shelter-based voucher holder was promised that Shamco would follow up with him about a particular unit, but, he was soon “ghosted” because of his voucher status.

Elected officials whose districts include areas where Shamco operates, reacted to the attorney general’s action, including Manhattan Borough President Mark Levine.

“With affordable housing nearly impossible to find in the city, Shamco discriminating against low-income New Yorkers is disgraceful,” Levine said. “No landlord is above the law, and everyone deserves safe and fair housing. I’m grateful to Attorney General James for holding Shamco accountable and fighting on behalf of New York’s most vulnerable renters.”

Congress Member Adriano Espaillat, who represents Harlem and other nearby areas, said “shame on Shamco” for denying the potential tenants fair housing access.

“No person in our country should be denied a place to call home because of their source of income, and any landlord who fails to comply with providing equitable and just services should be held accountable,” he said.