FDA 483 - Oxford Pharmaceuticals, LLC - May 22, 2019

An FDA inspection of Oxford Pharmaceuticals, LLC in Birmingham, AL, revealed significant deficiencies in their quality control unit, including a failure to conduct required Quality Management Review meetings and inadequate supplier auditing. The firm also lacked established procedures to prevent objectionable microorganisms in non-sterile drug products, specifically concerning their water generation plant. Additionally, deviations from written specifications and test procedures in their contracted microbiology laboratory were not justified.