FDA EIR - PEL Healthcare LLC - April 24, 2018

An FDA cGMP inspection of G&W PA Laboratories, LLC, a prescription pharmaceutical manufacturer located in Sellersville, PA, was conducted from April 9 to April 24, 2018. This routine inspection, which covered quality, production, facility, equipment, and validation, verified corrective actions from a previous 2016 inspection. The primary finding of the current inspection, documented as a single observation on Form FDA 483, concerned the company's failure to thoroughly review unexplained discrepancies and batch failures. This violated regulatory requirements under 21 CFR 211.192. Specifically, investigations into Out-of-Specification (OOS) results for several drug products were found to be incomplete. Examples included insufficient assessment of potential root causes in investigations for Eszopiclone Tablets (regarding an impurity), Buprenorphine Naloxone Sublingual Tablets (unknown impurity and oxidation), and Ketoconazole Tablets (storage/handling of active pharmaceutical ingredient). These deficiencies also related to Field Alert Reports. In response, management committed to implementing immediate corrective actions and providing a written reply to the FDA's Philadelphia District Director within 15 days.