L. Perrigo Company – FDA Warning Letter, Jan 14, 2010

An FDA inspection of L. Perrigo Company's pharmaceutical manufacturing facility from November 17, 2009, to January 14, 2010, revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's February 1, 2010, response was deemed insufficient. Violations included failure to reject drug products failing specifications, such as Ibuprofen contaminated with metal shavings, leading to a recall (21 CFR § 211.165(f)). The firm also failed to thoroughly investigate batch failures and extend investigations to other potentially affected batches (21 CFR § 211.192). Furthermore, the Quality Control Unit (QCU) repeatedly failed to follow written procedures (21 CFR § 211.22(d)), resulting in mislabeled products and Class II and III recalls, a recurring issue since 1998. Lastly, the firm failed to adequately inspect packaging and labeling facilities before use to prevent mix-ups, leading to foreign tablets in packaged lots (21 CFR § 211.130(e)), an ongoing problem despite a program initiated in 2005. FDA expressed concerns about the QCU's proactive compliance and the lack of sustainable corrective actions. The company must promptly correct these violations, provide a written response within fifteen working days detailing corrective actions, supporting documentation, and a timeline for equipment modifications. Failure to comply may result in legal action, including seizure and injunction, and impact federal contracts or drug application approvals.