Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
FDA issued a warning letter to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne (co-owner Praful Patel) following an October–November 2021 inspection that revealed serious insanitary conditions in sterile drug compounding operations. Violations included inadequate air-quality separation between ISO-classified areas, failure to segregate hazardous drug production, visibly dirty equipment with unknown foreign substances on HEPA filters, inadequate disinfection protocols, missing smoke studies, and insufficient aseptic process simulations (media fills). FDA found the firm's corrective-action responses deficient in multiple respects and warned that failure to adequately address violations may result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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