FDA 483 - Expert Compounding Pharmacy - March 04, 2022

An FDA inspection conducted at Expert Compounding Pharmacy from February 23 to March 4, 2022, revealed significant deviations from quality control and manufacturing standards for non-sterile drug production. The inspection identified six main observations, primarily concerning the facility's inability to ensure drug product safety, purity, and quality. Key issues included inadequate cleaning procedures for shared utensils, leading to potential cross-contamination of hazardous hormone drugs. The inspection also noted significant non-microbial contamination, such as dust build-up on air vents in the hormone room and dirt on porous ceiling tiles in general compounding areas, directly above exposed drug components. Furthermore, the firm was found to be using non-pharmaceutical grade components without adequate testing to confirm their quality. Crucially, Expert Compounding Pharmacy failed to perform essential quality control testing on both incoming raw materials and finished drug products for identity, strength, purity, and quality before release. This practice compromises the efficacy and safety of distributed medications. Finally, batch production records were deficient, lacking documentation of actual component weights and specific equipment used in manufacturing, hindering traceability. To address these findings, Expert Compounding Pharmacy must implement robust corrective actions, including enhancing cleaning validation, improving environmental controls, qualifying all raw materials, establishing comprehensive finished product testing, and ensuring accurate and complete batch record documentation to comply with regulatory requirements for drug manufacturing.