FDA EIR - Oxford Pharmaceuticals, LLC - May 22, 2019

An FDA Pre-Approval Inspection of Oxford Pharmaceuticals, LLC, located in Birmingham, AL, was conducted from May 14 to May 22, 2019. This initial inspection evaluated the company's readiness to manufacture drug products under an Abbreviated New Drug Application (ANDA) framework, covering its Quality System, Facilities and Equipment, Materials System, Packaging and Labeling, and Laboratory Control System.

The inspection revealed significant deviations from established manufacturing quality standards. Key issues included the quality control unit failing to consistently follow its own procedures, specifically regarding regular Quality Management Review meetings and the tracking of out-of-specification results. The firm also did not conduct required audits for several key suppliers, and its process for utilizing third-party audit reports was deemed incomplete.

Furthermore, procedures for preventing objectionable microorganisms, particularly concerning the purified water system, were inadequate. Critical devices within the water system were not properly monitored or maintained, and associated maintenance records lacked sufficient detail. Lastly, deviations from written specifications and test procedures at their contracted microbiology laboratory were not justified. This included incorrect media preparations, missing batch information in growth promotion studies, and out-of-range quality control results being erroneously accepted.

An FDA-483 form detailing these observations was issued to management. While some minor corrections were made during the inspection, Oxford Pharmaceuticals committed to addressing all remaining objectionable conditions and providing a written response to the agency.