Praful Patel
Co-Owner
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
5900 Balcones Dr, STE 100
Austin , TX 78731
United StatesFEI 3009192575Issued Aug 29, 2022Office of Pharmaceutical Quality Operations, Division II
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009192575.
Violations0
Issue DateAug 29, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
Location
Praful Patel
Co-Owner
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
5900 Balcones Dr, STE 100
Austin , TX 78731
United States
FEI Number
3009192575
Country
United States
Issue Date
August 29, 2022
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Open
Summary
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.
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne FDA Warning Letter, August 29, 2022