Compania Internacional de Comercio, S.A. de C.V. – FDA Warning Letter, Aug 25, 2011

On June 13, 2012, the FDA issued a Warning Letter to Compañía Internacional de Comercio, S.A. de C.V. following an August 22-25, 2011, inspection of their OTC drug manufacturing facility in Mexico. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Inadequate Laboratory Records (21 CFR 211.194(a)(4)):** Failure to control electronically generated worksheets, leading to discarded analytical data (e.g., COAs with differing assay values, unapproved worksheets, incomplete HPLC data). The firm must implement a remediation plan for raw data retention and conduct a retrospective investigation of analytical data, including justification for invalidating data and impact on US-shipped lots. 2. **Lack of Stability Testing Program (21 CFR 211.166(a)):** No written program or data to assess drug product stability, determine storage conditions, or establish expiration dates for OTC products exported to the US. The firm must provide documentation supporting current expiration dates and a commitment to an approved stability program, including details of any ongoing studies and assurance of stability-indicating, validated analytical methods. 3. **Insufficient Personnel Qualifications and Training (