FDA and EMA Compliance Actions in 2024: A Year in Review (Part 2)

In this continuation of our review of FDA and EMA compliance actions in 2024, we delve deeper into some of the most significant warning letters and non-compliance reports issued by these regulatory bodies.

Applied Therapeutics

The FDA issued a warning letter to Applied Therapeutics on December 3, 2024, following an inspection that revealed significant data integrity concerns. The inspection found discrepancies in clinical trial data, including missing source documents and inconsistencies in patient records.

• Failure to permit an authorized officer or employee of the Food and Drug Administration to have access to and copy and verify records and reports

• Failure to provide FDA with a description and analysis of any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from clinical investigations, including controlled and uncontrolled studies of uses of the drug other than those proposed in the application, commercial marketing experience, reports in the scientific literature, and unpublished scientific papers

Sichuan Deebio

The FDA issued a warning letter on February 5, 2024, highlighting significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API).

• Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures.

• Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.

EMA Non-Compliance Reports

In 2024, the Romanian authorities issued three consecutive GDP non-compliance reports.

1. An-Ra SRL: The responsible person failed to demonstrate knowledge of the provisions in the Good Distribution Practice Guide, as well as other legislative regulations applicable to the distribution of medicinal products for human use. Additionally, the unit show significant deficiencies in the organization and functioning of its quality management system. Furthermore, the unit's IT system was inadequate, unable to effectively support operational activities and meet the traceability and monitoring requirements mandated by current regulations.

2. Nova Farm SRL: Failure to notify NAMMDR 20 days before making an intra-community delivery.

3. Escu SRL: Procuring from entities which are not authorized for wholesaling activities, lack of appropriate documentation for reception and delivery, missing documentation of procuring such as invoice for certain products, incorrect reporting of distribution activities at NAMMDR.

Conclusion

The FDA and EMA's actions in 2024 underscore the importance of maintaining high standards in the pharmaceutical and food industries. These warning letters and non-compliance reports serve as a reminder of the critical need for robust quality management systems, proper staffing, and thorough training to ensure compliance with regulatory standards.