FDA 483 - Medi-Fare Drug - January 18, 2013

The FDA conducted an inspection of a Compounding Pharmacy in Blacksburg, SC, during December 2012 and January 2013, uncovering numerous critical deficiencies in its manufacturing and quality control operations. The inspection highlighted significant lapses in sterility assurance, environmental monitoring, and product release protocols. Key violations included a lack of validated sterilization processes for glassware and finished products, with inadequate documentation of sterilization cycles. Several drug products requiring sterilization had no records demonstrating this process, and vials were not rendered free from microbes using a validated cycle. Disturbingly, some products were distributed prior to receiving final sterility test results, referencing a specific lot of Testosterone Aqueous Suspension. The firm's environmental monitoring system for aseptic processing areas was found to be deficient, lacking proper procedures, real-time monitoring during operations, and complete documentation. Furthermore, Beyond-Use Dates (BUDs) were extended without supporting documentation, and the company failed to adequately sample for sterility and endotoxin testing, citing USP <797> and USP <71> as guidance. Other issues included persistent errors in formulation worksheets, including the use of expired chemicals, and a failure to thoroughly investigate critical quality events like product discoloration and particulate matter. The company also lacked procedures and documentation for the stability of stock solutions. These observations require immediate and comprehensive corrective actions to ensure product quality and patient safety.