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FDA Warning Letter Explorer
FDA warning letter · Drugs

Vita Pharmacy, LLC dba Talon Pharmacy of Boerne

Issued · Posted by FDA

FDA published a close-out letter on May 28, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm did not disinfect materials during transfer from the ISO7-classified cleanroom into the ISO5-classified area.

Passage 2

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO5 area. Specifically, smoke studies have never been performed in your ISO5-classified BSC.