FDA Issues Warning Letter for Repeated CGMP Violations and Quality Control Failures

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated 03 September 2024 to a Canadian over-the-counter (OTC) product manufacturer. The letter follows an inspection conducted in April 2024, discovering multiple violations of Current Good Manufacturing Practices (CGMP).

Key Findings

Key findings of the FDA include: 

• Failure to Perform Identity Testing on Components: The company did not adequately perform identity testing for all incoming components used in drug manufacturing. The firm's failure to conduct these tests raises concerns about the potential for contamination or mislabeling of their products. The company also relied on certificates of analysis (COA) from suppliers without verifying the identity of the components themselves, which further compounded the issue.
• Inadequate Validation of Manufacturing Processes: Another significant issue identified by the FDA was the company's failure to adequately validate its manufacturing processes. The inspection revealed that the firm did not establish and document the effectiveness of their manufacturing procedures through appropriate validation studies.
• Lack of Proper Oversight by the Quality Control Unit: The inspection further highlighted deficiencies in the quality unit (QU), which failed to ensure the consistent quality of drug products. The FDA noted that the QU did not have sufficient oversight to review and approve materials used in production, the manufacturing processes themselves, and the final product testing.

Repeat Violations

The letter emphasized that many of the current violations were previously identified in earlier inspections of the facility. In fact, the FDA had already issued a warning about similar problems in the past, yet the company had failed to implement sufficient corrective actions. This repeated non-compliance indicates a systemic failure to maintain proper manufacturing standards over time, and the FDA expressed serious concerns about the company's commitment to adhering to CGMP regulations.

Conclusion

In light of these significant violations, the FDA strongly recommended to hire an external consultant to assist in bringing their operations back into compliance. The FDA expects a detailed action plan to address the specific issues identified in the inspection report. If the company does not take adequate corrective measures, it may face further regulatory actions, including the seizure of products or legal injunctions. The company was already placed on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs").

For more detailed information, you can access the full Warning Letter on the FDA's website.