FDA EIR - Belcher Pharmaceuticals, LLC - May 13, 2016

Belcher Pharmaceuticals, LLC underwent a comprehensive FDA inspection from April 25 to May 13, 2016. This extensive audit covered cGMP, pre-approval, and post-approval requirements for human and animal drug manufacturing, specifically focusing on Quality, Production, and Laboratory Control Systems under the Food, Drug & Cosmetic Act. The inspection resulted in nine significant observations documented in an FDA Form 483. Prominent violations included deficiencies in laboratory records, such as incomplete instrument calibration and unestablished accuracy of test methods. Investigations into out-of-specification results lacked adequate conclusions and follow-up, and the quality control unit failed to fully implement its procedures. Other critical issues identified were unjustified deviations from written laboratory mechanisms, insufficient periodic visual examination of reserve drug samples for deterioration, and inadequate employee training in specific operational and good manufacturing practices. Furthermore, the firm did not consistently follow or contemporaneously document written production and process control procedures, and lacked formal written procedures for post-marketing adverse drug experience surveillance and reporting. Notably, three of these observations were repeats concerning the Quality System. Belcher Pharmaceuticals' President committed to submitting a written response outlining corrective actions within 15 business days. The FDA emphasized the firm's responsibility for regulatory adherence and informed them of potential enforcement actions, including warning letters, seizures, injunctions, and penalties, for continued non-compliance.