FDA 483 - Vita Pharmacy, LLC dba Talon Compounding Pharmacy - August 03, 2018

This FDA Form 483 details observations from an inspection, highlighting multiple deficiencies in facility design, aseptic processing, quality control, and environmental monitoring.

**Facility and Operations:** The facility includes an ISO 7 cleanroom with an ISO 5 aseptic processing area and an ISO 8 anteroom. The firm aseptically compounds sterile patient-specific finished drug products.

**Violations and Observations:**

* **Observation 1:** The facility design allowed poor quality air from the ISO 8 anteroom (differential pressure +0.029") to flow into the higher-classified ISO 7 cleanroom (differential pressure +0.026"). The firm failed to document, investigate, and correct this issue, despite aseptically compounding sterile products on the same day (8/14/2017). * **Observation 2:** Personnel engaged in aseptic processing had exposed hair, with a pharmacy technician's hair observed sticking out from under a hairnet on 7/26/2018. The technician's entire head extended into the ISO 5 area multiple times while compounding sterile Tri-Mix Injection lots. * **Observation 3:** Personnel failed to disinfect gloves to prevent contamination. On 7/26/2018, 7/31/2018, and 8/1/2018, a pharmacy technician left the ISO 5 area to