FDA WARNING_LETTER - Vita Pharmacy, LLC dba Talon Pharmacy of Boerne - November 02, 2021

The FDA inspected Vita Pharmacy, LLC dba Talon Pharmacy of Boerne from October 18 to November 2, 2021, identifying serious deficiencies in sterile drug product production, leading to a Form FDA 483. The firm's response dated November 15, 2021, was acknowledged but deemed deficient in several areas.

The FDA found drug products to be adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Specific violations included: 1. **Facility Design/Airflow:** Inadequate sealing of the curtain separating ISO5 and ISO7 areas, and a visible crack in the wall between ISO7 and ISO8 spaces, potentially allowing lower quality air influx. 2. **Cross-Contamination:** Hazardous drug products produced in the same ISO7 cleanroom as non-hazardous products without adequate containment. 3. **Dirty Equipment:** Visibly dirty equipment and difficult-to-clean surfaces, including an unknown foreign substance on a HEPA filter grille in the ISO5 area. 4. **Disinfection Failure:** Failure to disinfect materials during transfer from ISO7 to ISO5 areas. 5. **Inadequate Smoke Studies:** No smoke studies performed in the ISO5-classified biological safety cabinet (BSC) under dynamic conditions. 6. **Insufficient Media Fills:** Media fills not performed under the most challenging or stressful conditions