Mylan LLC. – FDA Warning Letter, Feb 24, 2011

The FDA issued a Warning Letter to Mylan LLC following an inspection of their Caguas, Puerto Rico pharmaceutical manufacturing facility from January 24 to February 24, 2011. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Specific violations include: 1. Failure to complete appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR § 211.165(a)). For example, Loperamide Hydrochloride Capsules USP 2mg (lot 3021292) failed the content uniformity (CU) test, but the firm did not provide scientific rationale for not completing the test. 2. Failure to thoroughly investigate out-of-specification (OOS) results (21 CFR § 211.192). The firm attributed OOS results to assignable causes without sufficient supporting evidence or scientific rationale to invalidate initial data.

Mylan's March 14, 2011, response was deemed insufficient. The FDA requires prompt corrective action to prevent recurrence of these and other violations. Failure to comply may result in legal action, including seizure and injunction, withholding of export certificates, and denial of pending drug applications. Mylan must provide a written response within fifteen working days detailing corrective steps