FDA WARNING_LETTER - McGuff Pharmaceuticals Inc. - June 02, 2010

On December 28, 2010, the FDA issued a Warning Letter to McGuff Pharmaceuticals Inc. following an inspection from May 18 to June 2, 2010. 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. Additionally, the firm was found to be distributing unapproved new drugs and misbranded drugs, violating sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act. The firm's June 16, 2010 response was deemed insufficient.

Key CGMP violations included: 1. Failure to establish appropriate written procedures to prevent microbiological contamination of sterile drug products, including inadequate validation of aseptic and sterilization processes (21 CFR § 211.113(b)). Examples cited were insufficient media fill configurations (using (b)(4) volume for media fills when commercial products are (b)(4) and (b)(4)), lack of maximum aseptic fill duration, and inadequate qualification of the Getinge Model 4300 autoclave and Grieve CLE-500 oven with representative loads, biological indicators, and penetration thermocouples. 2. Failure to conduct at least one specific identity test and establish the reliability of supplier analyses for Active Pharmaceutical Ingredients (