FDA WARNING_LETTER - Tedec-Meiji Fanna, S.A. - July 22, 2011

On April 24, 2012, the FDA issued a Warning Letter to Tedec-Meiji Farma, S.A. following an inspection from July 18-22, 2011, which identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render their drug products adulterated.

Key violations include: 1. **Inadequate Out-of-Specification (OOS) Investigations (21 CFR § 211.192):** The firm failed to thoroughly investigate an OOS result for Lot # (b)(4) of (b)(4) tablets, which failed assay specifications during stability testing. The investigation was untimely, lacked a root cause, and did not extend to other batches or production operations. The firm's response was insufficient, lacking scientific rationale for invalidating the initial OOS result and a comprehensive review of OOS investigations. 2. **Unreliable Supplier Analyses (21 CFR § 211.84(d)(2)):** The firm did not adequately qualify drug component suppliers for (b)(4) tablets, failing to verify COA accuracy, conduct (b)(4) testing during qualification, or validate test results at appropriate intervals. The firm continued to rely on unqualified vendors. 3. **Inadequate Specifications and Test Procedures (