Strive Pharmacy Texas LLC dba Strive Pharmacy – FDA 483, Nov 2, 2021

This FDA Form 483 was issued to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne, a producer of sterile drug products, located at 1430 South Main Street #105, Boerne, TX 78006. The inspection occurred from October 18-22, 25-27, 2021, and November 2, 2021.

The inspection revealed six observations:

1. **Facility Design Deficiencies:** The facility design may allow poor quality air into higher classified areas. This includes a visible gap between the ceiling and a barrier separating ISO 5 and ISO 7 areas, (b)(4) doors lacking safeguards for differential pressure changes, a crack in the ISO 7 cleanroom wall allowing ingress from the ISO 8 area, and a power cord obstructing an exhaust vent between ISO 8 and ISO 7, allowing dust ingress. 2. **Inadequate Hazardous Drug Containment:** Hazardous drugs were produced without adequate containment and segregation to prevent cross-contamination. The ISO 5 Biological Safety Cabinet for hazardous sterile drug products is located in the ISO 7 cleanroom, close to the ISO 5 workbench area. 3. **Residue on HEPA Filter Grille:** A dark residue was observed on the plastic grille enclosing the HEPA filter in the ISO 5 workbench area. 4. **Improper Material Disinfection