FDA 483 - Barclay, Luke, & Pillai Specialty Pharmacy, PLLC - December 09, 2022

Barclay, Luke, & Pillai Specialty Pharmacy, PLLC was cited for significant deficiencies in aseptic processing and quality control during an FDA inspection. Observations included visibly dirty ISO 5 areas, widespread non-microbial contamination in cleanrooms, inadequate containment for hazardous drugs, and a failure to perform analytical testing for both finished drug products and raw materials. These issues indicate a severe lack of control over the sterile manufacturing environment and product quality.