I got a post on my RSS feed today from the FDA for a closeout letter to Safecor Health in response to the 2023 Warning Letter. Always happy to see an actual closeout letter.
The main takeaways from the FDA warning letter:
Inadequate Line Clearance and Packaging Controls:
- Safecor failed to properly inspect packaging and labeling facilities before use, leading to potential mix-ups of drug products. This was evidenced by the presence of unrelated tablets and capsules during the packaging of a specific product.
- The company has a history of product mix-ups, including instances where a vitamin was found in a drug meant to prevent organ transplant rejection and mislabeled blood clot prevention medication.
Insufficient Cleaning and Maintenance Procedures:
- The firm lacked adequate procedures for cleaning and maintaining equipment, with unidentified residues found on supposedly clean equipment. This poses a risk of cross-contamination.
- The company’s cleaning validation program was deemed inadequate, particularly in addressing worst-case scenarios.
Failure to Test Components:
- Safecor did not adequately test incoming components, such as water used in drug manufacturing, for purity, strength, and quality.
- The company relied on visual inspections without performing necessary chemical and microbiological tests.
Quality Control Unit Deficiencies:
- The quality control unit failed to ensure compliance with CGMP regulations, including inadequate document control and data integrity issues.
- Manufacturing records were not properly controlled, and corrections were made using correction fluid, raising concerns about data authenticity.
Investigations of a Dog 