Vita Pharmacy, LLC dba Talon Compounding Pharmacy – FDA 483, Jun 24, 2015

The FDA inspection identified significant deficiencies at the facility, particularly concerning aseptic processing and quality control for sterile and non-sterile drug products.

**Facility and Operations:** The ISO-5 cleanroom has structural issues, with openings around the perimeter covered by plastic flaps that allow continuous airflow from the cleanroom into an unclassified area, compromising aseptic conditions. There are no smoke studies to verify airflow direction in the ISO-5 cleanroom.

**Violations and Observations:**

* **Aseptic Processing Environment:** * Deficient systems for maintaining aseptic conditions due to structural design of the ISO-5 cleanroom. * Lack of smoke studies to verify airflow. * Inadequate cleaning and disinfection procedures; the SOP specifies "All cleaning activities should take place" but lacks specific details. * Environmental monitoring records are inconsistent and incomplete, with missing data for certain tests and varying monitoring durations. * **Personnel Gowning:** * Personnel clothing is inappropriate; an operator's sleeve contacted the floor of the anteroom before entering the ISO-5 cleanroom, with no corrective action. Non-sterile gowning garb was provided by the firm. * **Product Stability and Testing:** * No written testing program for assessing drug product stability. * No written procedure for evaluating "Beyond Use Dates" (BUDs) for "non-sterile to sterile products," designated as "High risk compounding