Mandell's Clinical Pharmacy – FDA 483, Jun 17, 2022

This FDA Form 483 documents observations from an inspection related to aseptic drug product manufacturing. The facility's media fills, intended to simulate aseptic production, were found inadequate. Specifically, the media fill for Progesterone Ethyl Oleate 100mg/ml, Progesterone Ethyl Oleate 50mg/ml, and Progesterone Olive Oil 50mg/ml, which are (b)(4), did not represent the most challenging conditions. Other production processes, such as those for Micro Dose Leuprolide Acetate 50mcg/0.2ml and Leuprolide Trigger Prefilled syringes, require (b)(4), indicating a lack of worst-case simulation.

Personnel were observed donning gowning apparel in a manner that could lead to contamination. Furthermore, there was no assurance that sterile drug products were processed and stored under ISO 5 quality air. On June 1, 2022, during aseptic processing of Micro Dose Leuprolide Acetate 50mcg/0.2ml (Lot #220601A), a pharmacist's hands were observed resting on the return vent of the ISO 5 Biosafety Cabinet.

Finally, procedures to prevent microbiological contamination lacked adequate validation of the sterilization process. Current airflow studies (smoke studies) for the ISO 5 Biosafety Cabinet were not performed under conditions representative of current production practices, nor did they emulate all critical unit operations and interventions used during sterile