FDA WARNING_LETTER - Wyeth Lederle S.p.A - July 20, 2012

This FDA Warning Letter, dated March 27, 2013, was issued to Wyeth Lederle S.p.A. following an inspection from July 9-20, 2012, at their Catania, Italy, pharmaceutical manufacturing facility. The inspection identified significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Additionally, violations of Section 505(k) of the Act and 21 CFR 314.81 regarding record-keeping and reporting for approved drugs were cited.

Key violations include: 1. **Failure to thoroughly investigate unexplained discrepancies (21 CFR 211.192):** The firm failed to adequately investigate out-of-specification (OOS) endotoxin results for Torisel Diluent batch AGMV/1, reported on April 17, 2012. Despite extensive re-testing across multiple platforms and laboratories, inconsistent passing and failing results persisted. The firm's proposed root cause of interference from secondary packaging components lacked scientific justification, and the investigation did not initially include the portion of the batch distributed to the U.S. market. 2. **Failure to submit NDA/ANDA Field