FDA 483 - Barclay, Luke, & Pillai Specialty Pharmacy, PLLC - December 14, 2018

The FDA Form 483 details numerous deficiencies at a facility producing purportedly sterile drug products, including injectables and pellets.

Key violations include: - **Sterility Assurance:** Procedures for preventing microbiological contamination are not established or followed. The ISO 5 laminar flow hood certification lacked documentation of dynamic condition simulation and airflow visualization. Media fill challenge tests were not conducted every six months as required. - **Sterilization Validation:** The firm did not include biological indicators in sterilization loads for drug products, and sterilization parameters for Stanozolol 50 mg/mL were not validated. - **Environmental Control:** Environmental and personnel monitoring during sterile drug production is not performed. Cleanroom, anteroom, and ISO 5 laminar flow hood certifications were not performed annually. A HEPA filter was absent over an area where sterile product was exposed. - **Aseptic Processing & Personnel:** Pellets purportedly sterile are produced in a non-sterile, negative pressure, unclassified room. Cleaning and disinfecting systems for aseptic areas are deficient, using non-sterile wipes and mop heads. Personnel clothing was inappropriate, with exposed skin observed around goggles during production. - **Quality Control & Testing:** Discrepancies in biological indicator test results were not investigated. Glassware used for non-sterile bulk drug substances was not depyrogenated. Hold times for cleaned, uncovered glassware were not determined. Stability programs are inadequate, lacking sterility testing at end of shelf life. Sterility, endotoxin