Calvin Scott & Company, Inc. – FDA Warning Letter, Mar 12, 2020

The FDA inspected Calvin Scott and Company Inc.'s drug manufacturing facility in Albuquerque, New Mexico, from March 9-12, 2020, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include: 1. **Lack of Stability Data (21 CFR 211.137(a)):** The firm repackaged drug products, like hydrochlorothiazide tablets, into non-equivalent container-closure systems (heat-sealed pouches with one transparent side) without supporting stability data for assigned expiration dates. The FDA found their response inadequate as it didn't address moisture/oxygen transmission or container-product compatibility, and lacked a stability protocol/data. Corrective actions require a comprehensive stability program assessment, CAPA plan, stability-indicating methods, ongoing studies, and detailed procedures. 2. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm used non-dedicated repackaging lines without cleaning validation studies to prevent cross-contamination. Their response, acknowledging no cleaning validation, was deemed inadequate for not demonstrating cleaning program effectiveness. Required actions include a comprehensive cleaning program assessment and CAPA plan, improvements to cleaning effectiveness, enhanced ongoing verification, and a robust cleaning validation program addressing worst-case scenarios. 3. **Deficient Quality Control Unit (21 CFR 211.22(a)):** The firm lacked an independent Quality Unit