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Vita Pharmacy, LLC dba Talon Pharmacy of Boerne, a compounding pharmacy, was cited for manufacturing sterile drug products under insanitary conditions that violated federal manufacturing standards. FDA inspectors identified critical deficiencies including inadequate air quality controls—specifically an improperly sealed curtain and visible crack in the ISO 7-classified area separating it from the ISO 5-classified compounding space—that could allow contamination and render products adulterated and injurious to health. The facility's design and operational failures created a direct risk to patients by permitting lower-quality air to infiltrate sterile production areas during the October-November 2021 inspection.