FDA 483 - KV Pharmaceutical Co Westport - February 02, 2009

An FDA inspection of KV Pharmaceutical Co. Westport, conducted from December 15, 2008, to February 2, 2009, revealed significant deficiencies in the company's manufacturing and quality control systems. The observations cited in the FDA Form 483 highlight a failure to adhere to Current Good Manufacturing Practices (CGMP). Key issues included a systemic breakdown in the quality control unit, evidenced by the undocumented blending of sub-standard drug components for Metoprolol Succinate tablets and the release of rejected Oxycodone batches. The company also failed to address hundreds of consumer complaints regarding leaking Prenatal Multivitamin capsules and continued distributing the product. Process validation and control procedures were inadequate, leading to variable product quality across several lines, including Metoprolol Succinate, Hydromorphone HCl, and Morphine Sulfate ER tablets. This manifested in numerous batch rejections, out-of-specification results, and persistent acceptable quality limit (AQL) failures related to tablet defects, despite equipment upgrades. Critical manufacturing parameters, like compression force, were often not recorded or controlled. Furthermore, investigations into manufacturing discrepancies and product failures were frequently incomplete or absent, lacking root cause analysis and appropriate corrective and preventive actions (CAPAs). For instance, issues like dissolution failures due to excessive press speed or cap torque problems were identified but not effectively resolved, leading to ongoing non-compliance and continued production of potentially compromised products. The company is required to implement comprehensive and effective CAPAs to rectify these serious observations and ensure compliance with regulatory standards.