Farma Quimia S.A. de C.V. – FDA Warning Letter, Sep 15, 2011

This FDA Warning Letter to Farma Quimia S.A. de C.V. resulted from a September 12-15, 2011 inspection of their API manufacturing facility in Cuautitlan, Izcalli, Mexico. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for API manufacturing, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Incomplete Batch Production Records:** Records lacked essential information like equipment identity, sampling details, and personnel signatures. Temperature logging for a critical process step was insufficient. 2. **Inadequate Quality Unit Oversight:** The quality unit failed to review and approve analytical release testing, executed production batch records, and master batch production records before release or execution. 3. **Lack of In-Process Controls:** No in-process testing or established specifications for the API intermediate (b)(4) (b)(4) were in place. 4. **Unvalidated Operations:** The manufacturing processes for (b)(4) USP (API) and (b)(4) (API intermediate) were not validated, despite significant quantities of API being released to the U.S. market. 5. **Uncalibrated Equipment:** Manufacturing scales, autoclaves, incubators, UV spectrophotometers, and pH meters were past due for calibration or lacked calibration records. Analytical balances were not