FDA 483 - ideal specialty apothecary, inc. - November 18, 2021

An FDA inspection conducted from September 13 to November 18, 2021, at Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy, a compounding pharmacy in Union, New Jersey, identified several significant issues related to their manufacturing and control practices, many of which were repeat observations. Key violations included the failure to properly certify ISO-5 classified areas under dynamic operational conditions, with smoke studies not accurately simulating compounding activities. Media fill simulations were found to be inadequate, lacking worst-case scenarios, full batch sizes, and critical processes like vial foiling outside the sterile environment. The ISO-5 cleanroom itself was located within a non-classified area, operating with insufficient pressure differentials, and confirmed microbial contamination was present in both classified and unclassified zones.

Additional concerns involved compromised sterility assurance for finished products, as punctured vial stoppers were exposed to non-sterile conditions during post-filling and storage in corroded environments. Non-microbial contamination, such as rust on sterilization equipment, carts, and shelves, as well as discolored HEPA filters and stained ceilings, was observed throughout the facility. Furthermore, vermin, including live insects and dead flies, were noted in areas adjacent to compounding and sterile product storage, posing a direct contamination risk. The firm also compounded drugs during ongoing construction in an adjacent area without adequate controls to prevent product contamination. Ideal Specialty Apothecary, Inc. is required to provide comprehensive corrective actions to address these serious observations.