FDA 483 - Boothwyn Pharmacy LLC - October 22, 2024

This FDA Form 483 details significant deficiencies in a drug manufacturing operation, primarily concerning quality control and sterile product procedures.

**Observation 1** highlights failures in drug product testing and release. The firm distributed seven batches of drug products, including HA/CHONDROITIN/ACETYL-D-GLUCOSAMINE (100Ml) 5MG/50MG/150MG/Ml INJ SOLUTION, with false passing bacterial endotoxin testing (BET) results on Certificates of Analysis (COAs), despite the contracted laboratory's database indicating Out of Specification (OOS) results. Additionally, approximately thirty-one compounded drug products, such as Pentosan and Glucosamine injection solution, lot # 01152024, were distributed despite confirmed OOS BET results. The firm also failed to conduct BET for approximately six batches of glucosamine-containing products, including various HA/CHONDROITIN/ACETYL-D-GLUCOSAMINE and PENTOSAN POLYSULFATE AND GLUCOSAMINE injection solutions, before distribution.

**Observation 2** addresses inadequate procedures to prevent microbiological contamination in sterile drug products. Air visualization "smoke" studies were insufficient; media fills and smoke studies were not representative of production operations, with a second operator entering the ISO 5 environment while the filling technician was present, violating SOP CP.CTECH.0040.000