Empower Clinic Services, LLC dba Empower Pharmacy
FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX) following a September–October 2024 inspection that identified serious insanitary conditions in the production of sterile injectable drug products. Investigators found failures in environmental monitoring, inadequate media fills, and unsterilized equipment components contacting injectable drug product stoppers, rendering the compounded products adulterated under FDCA section 501(a)(2)(A). FDA found the firm's corrective action responses insufficient and lacking supporting documentation. The letter warns that failure to adequately address violations may result in seizure and 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. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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