FDA 483 - Stonegate Pharmacy LP - August 09, 2019

Stonegate Pharmacy LP, a producer of sterile drug products in Austin, TX, was cited for significant deficiencies in aseptic processing and quality control. Observations included improper gowning, inadequate containment for hazardous drugs, failure to disinfect materials entering sterile areas, and issues with equipment cleanliness. Furthermore, the firm released drug products without proper calibration records, using non-calibratable thermometers, and unverified starting materials, raising concerns about product quality and purity.