FDA EIR - Aurora Medbiochem Company - September 04, 2014

A follow-up FDA compliance inspection of Aurora Medbiochem Company, an OTC drug manufacturer in Escondido, CA, was conducted from September 2-4, 2014. Operating under the Food, Drug and Cosmetic Act and applicable Current Good Manufacturing Practices (CGMP) regulations, the inspection revealed substantial and repeat deficiencies. Key issues included the quality control unit's failure to adequately review batch production and control records, which were themselves deficient in critical details such as actual and theoretical yields, container descriptions, labeling examination results, component lot numbers, personnel identification for significant steps, equipment identification, in-process controls, and packaging area inspection results. The company also lacked crucial process validation for its 'Pain Relieving Ointment' and 'Pain Relieving Oil' products and had no stability program to assess product shelf-life. Additionally, essential personnel had not received updated GMP training since 2006, and laboratory controls were insufficient, with no testing performed for active ingredient identity and strength prior to product release. During the inspection, the firm received notification from the State of California regarding manufacturing drugs without a license. In response, Aurora Medbiochem Company ceased drug manufacturing immediately, committing to obtain a state license, renew FDA registration, and provide a written response to the FDA addressing all CGMP deficiencies within fifteen business days.