FDA 483 - Expert Compounding Pharmacy - March 04, 2022

Expert Compounding Pharmacy in Lake Balboa, CA, a producer of non-sterile drugs, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate cleaning procedures leading to cross-contamination of hormone drugs, widespread non-microbial contamination in production areas, and the use of non-pharmaceutical grade components without proper testing. Furthermore, the firm failed to perform essential quality control testing on both finished drug products and incoming raw materials, and maintained deficient batch production records lacking critical manufacturing details.