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# Multiple Violations Found at Wellness Pharmacy
- URL: https://www.fdaweb.com/multiple-violations-found-at-wellness-pharmacy/
- Published: 2016-04-05T12:00:00.000Z
- Updated: 2026-09-14T20:53:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135278

> A 3/9-3/12/15 FDA inspection at the Wellness Pharmacy, Winchester, Virginia, identified multiple violations in the firm’s compounding of sterile drug products. Wellness has informed FDA that it stopped producing compounded sterile drugs as of 3/12/15\. A 3/23 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm492676.htm?ref=fdaweb.com) from the agency Baltimore District Office says that specific violations included:  
> failing to receive valid prescriptions for individually-identified patients for a portion of the drug products produced; compounding drug products intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners such that adequate directions for their use cannot be written so that a layman can use the products safely for their intended uses; drugs intended to be sterile were prepared, packed, or held under insanitary conditions; failing to establish an adequate system for maintaining equipment used to control aseptic conditions; failing to establish and follow appropriate procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions; failing to ensure that manufacturing personnel wear clothing appropriate to protect the drug products from contamination; and failing to establish an adequate system for monitoring environmental conditions in aseptic areas.  
>  
> The letter says that if the pharmacy decides to resume production of sterile drugs, FDA strongly recommends that it undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials, and systems, with particular attention to aseptic processing operations. The agency suggests that a third-party consultant with relevant sterile drug manufacturing experience could be useful in conducting the comprehensive evaluation.