FDA 483 - Dougherty's Pharmacy - December 29, 2015

This FDA Form 483 was issued to Dougherty's Pharmacy, a producer of sterile drug products in Dallas, TX, on December 29, 2015, following an inspection from December 8-29, 2015. The document lists twelve observations indicating significant deficiencies in their manufacturing and quality control processes for sterile drug products.

Key violations include: * **Lack of Sterility and Endotoxin Testing:** Numerous sterile and non-sterile to sterile products, including Alprostadil USP, were released without sterility testing from June to September 2015. The in-house sterility test method used was unvalidated, and endotoxin testing was not performed for non-sterile to sterile products. Non-sterile products with extended Beyond Use Dates (BUDs) lacked sterility testing and verification. * **Inadequate Product Testing and Release:** The firm failed to conduct potency testing for 111 batches of sterile finished products released between June and December 2015, many with BUDs of 90-180 days. Preservative content testing was also not performed for sterile formulations containing preservatives. * **Deficient Laboratory Controls:** The product inspection process lacked 100% visual checks against a contrasting background for sterile liquid formulations, and no written procedure for visual checks existed. * **Poor Environmental Monitoring and Aseptic Practices:** No environmental monitoring (air, personnel,