Polimeros y Servicios S.A. – FDA Warning Letter, Feb 8, 2019

The FDA issued a Warning Letter to Polimeros y Servicios S.A. following an inspection from February 4-8, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Lack of Finished Product Testing:** The firm failed to test OTC finished drug products for identity and strength of active ingredients before release (21 CFR 211.165(a)). Their response, proposing third-party testing, was inadequate due to insufficient detail on procedures and methods. 2. **Inadequate Component Testing:** The firm did not test incoming APIs and raw materials for identity, purity, or strength, relying solely on supplier analyses without validation (21 CFR 211.84(d)(1) and (2)). Their proposed six-month extension and supplier qualification program were deemed inadequate, lacking commitment to cease manufacturing and a risk assessment for distributed products. 3. **Insufficient Stability Testing:** The firm failed to support drug product expiration dates with adequate stability testing (21 CFR 211.137(a)), lacking data for a three-year expiry. Their response, citing financial constraints and technical issues, was inadequate, failing to provide stability protocols or actions for distributed products. 4. **Inadequate Equipment Cleaning Procedures:** The firm used non-dedicated equipment without validated cleaning processes to prevent cross-contamination (21 CFR