FDA 483 - Vita Pharmacy, LLC dba Talon Compounding Pharmacy - October 06, 2021

An FDA inspection of Vita Pharmacy, LLC dba Talon Compounding Pharmacy in San Antonio, TX, a sterile and non-sterile drug producer, revealed significant deficiencies in facility design, cleanroom certification, and hazardous drug handling. Repeat observations highlighted issues with maintaining air quality in classified areas and ensuring proper certification under dynamic conditions. The firm also failed to adequately contain and segregate hazardous drug products, raising concerns about cross-contamination.