Joe Wise Pharmacy, Inc., dba Wise Pharmacy
FDA issued a warning letter to Joe Wise Pharmacy, Inc. dba Wise Pharmacy (Littleton, CO) following a June 2019 inspection that found serious insanitary conditions in the production of sterile and non-sterile drug products. Violations included operating an ISO 5 workstation in a non-classified room, inadequate cleaning of hazardous drug hoods, failure to perform proper smoke studies, and deficient environmental monitoring — all causing drug products to be adulterated under FDCA section 501(a)(2)(A). The firm had already voluntarily recalled all sterile products and ceased sterile compounding as of July 10, 2019, but FDA found the corrective actions incomplete and warned that failure to fully remediate could result in seizure or injunction.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to correct the violations cited in this letter.
you should notify this office fifteen (15) days prior to resuming production of any sterile drugs in the future.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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