Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
WARNING LETTER SANOFI AVENTIS DEUTSCHLAND GmbH
WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH (con't) 2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example, a) The airflow velocity inside critical areas of the aseptic processing operations of Line … [Read more...]
SANOFI AVENTIS DEUTSCHLAND GmbH WARNING LETTER
WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. Comment 21 C.F.R. § 211.113(b) states that "appropriate written procedures, designed to prevent microbiological … [Read more...]
Warning Letter McGuff Pharmaceuticals CGMP Violations 12/28/10
McGuff Pharmaceuticals Inc 12/28/10 Warning Letter CGMP Violations  Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. §211.192] For example, your firm failed to conduct adequate investigations into action level … [Read more...]
