FDA 483 - Isomeric Pharmacy Solutions, LLC - August 28, 2015

During an inspection conducted from August 24 to August 28, 2015, Isomeric Pharmacy Solution, LLC, an outsourcing facility, was issued an FDA 483 form detailing significant deviations from regulatory standards. The inspection revealed critical issues primarily related to sterile drug product manufacturing and labeling. Key violations included a lack of adequate validation for terminal sterilization processes and equipment, specifically for a moist heat autoclave used for Triamcinolone Acetonide/Lidocaine HCL injectable suspension. The firm also failed to perform in situ air pattern analysis under dynamic conditions, compromising the assurance of suitable aseptic processing environments.Environmental monitoring was found deficient, with no viable or non-viable air sampling conducted in critical ISO 5 laminar flow hoods during compounding operations, and particle counter placements lacked scientific justification. Furthermore, the company had no written stability testing program to support drug product beyond-use dating and failed to test preservative content at the time of product release. Finally, numerous drug product labels were non-compliant with Sections 503B(a)(10)(A) and (B) of the Food, Drug, and Cosmetic Act, missing essential information such as mandatory compounded drug statements, storage instructions, compounding dates, route of administration, and adverse event reporting details. The company is required to implement comprehensive corrective actions to address these serious deficiencies and ensure compliance with regulatory standards for sterile compounding and labeling.