FDA 483 - Boothwyn Pharmacy LLC - September 08, 2021

An FDA inspection of Boothwyn Pharmacy LLC in Kennett Square, PA, revealed significant deficiencies in the production of both sterile and non-sterile drug products. Observations included inadequate aseptic processing techniques, insufficient cleaning and disinfection procedures, and a lack of proper environmental controls and quality assurance for critical processes like media fills and water quality. These issues indicate a failure to maintain a state of control necessary for drug manufacturing.