FDA 483 - The Compounding Shop, Inc. - March 22, 2013

During an FDA inspection conducted from March 18-22, 2013, The Compounding Shop, Inc., a producer of sterile drugs, received a Form FDA 483 for significant violations of Current Good Manufacturing Practice (cGMP). The inspection identified twelve major observations, primarily concerning the facility's procedures for preventing microbiological contamination and ensuring sterile drug quality.Key issues included a widespread failure in aseptic processing techniques, such as improper hand sanitization, handling of sterile components, and deficient media fill simulations that did not represent worst-case conditions. The company's environmental monitoring system was critically flawed, lacking adequate written procedures, consistent sampling, accurate record-keeping, and investigation of excursions. Furthermore, essential equipment, including ISO 5 hoods and stainless steel tables, showed signs of rust and contamination, indicating poor maintenance.The firm also failed to validate sterilization and depyrogenation processes for its drug products and components, lacking bioburden limits and sufficient documentation. Product testing and release procedures were inadequate, with many injectable and intrathecal drugs not routinely tested for potency, sterility, or endotoxin prior to distribution. Stability data was missing to support assigned expiration dates for several products. Finally, personnel practices, such as gown re-use, and equipment calibration, including refrigerator and autoclave thermometers, were found to be deficient or non-existent.The FDA requires The Compounding Shop to promptly address these serious deficiencies to ensure compliance with cGMP regulations and the safety and quality of its sterile drug products.