West-Ward Pharmaceuticals Corp. – FDA Warning Letter, Jun 30, 2011

An FDA inspection of West-Ward Pharmaceuticals Corp.'s Eatontown, New Jersey facility from June 13-30, 2011, revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's July 21, 2011 response was deemed insufficient. Key violations include the failure to establish adequate control procedures to monitor manufacturing processes and validate performance, leading to variability in drug product characteristics, as required by 21 C.F.R. § 211.110(a). Specifically, SOPs allowed release of batches with significant in-process defects like out-of-specification thickness and hardness for tablets, and inadequate process controls for Lithium Carbonate ER Tablets. The firm also failed to thoroughly investigate out-of-specification (OOS) results for batches, including issues with dissolution testing for Lithium Carbonate ER Tablets due to an incorrect degassing technique and a lack of retrospective impact assessment, and aberrant Digoxin tablets (overweight) without proper root cause analysis or process control evaluation, violating 21 C.F.R. § 211.192. Additionally, master production and control records lacked theoretical yield statements and investigation requirements (21 C.F.R. § 211.186(b)(7)), and equipment used in manufacturing was not of appropriate design for its intended use (21 C.F.R. § 211.63), with inadequate qualification of Tablet Testing System (TTS) machines and the Pressure Control Device (PCD)-2 Automatic Tablet Weight Control System. The FDA noted that several deficiencies cited in a previous February 2010 inspection remained uncorrected. West-Ward Pharmaceuticals must promptly correct these violations within fifteen working days, providing a written response detailing corrective actions and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and impact contract awards, export certificates, and pending drug applications.