FICOSOTA LTD – FDA Warning Letter, Sep 5, 2019

The FDA issued a Warning Letter to FICOSOTA LTD. in Shumen, Bulgaria, following an inspection from September 2-5, 2019, which revealed significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm did not perform identity and strength testing for each batch of their OTC drug product "(b)(4)" prior to release, violating 21 CFR 211.165(a). 2. **Inadequate raw material testing:** The firm failed to test incoming raw materials for identity, purity, strength, and quality, relying on supplier COAs without a robust supplier qualification program, violating 21 CFR 211.84(d)(1) & (2). 3. **Deficient Quality Control Unit (QCU) oversight:** The QCU failed to ensure CGMP compliance, including approving/rejecting materials, reviewing testing, monitoring process control, adequate master/batch records, annual product reviews, and OOS investigations. The QCU was also not independent from production, violating 21 CFR 211.22. 4. **Inadequate stability program:** The firm lacked a written stability testing program, including long-term studies with chemical and microbial testing, to support expiration dates, violating 21 CFR 211.166(a