FDA 483 - Purdue Pharmaceuticals LP - December 19, 2019

Purdue Pharmaceuticals Lp, a narcotics drug products manufacturer in Wilson, NC, was cited for significant deficiencies in its investigation processes. The firm failed to thoroughly assess and address unexplained discrepancies, out-of-specification results, potential contamination sources, and consumer complaints. These issues indicate a systemic problem with the company's quality control and corrective action procedures.