FDA warning letter cites Empower Pharmacy for insanitary conditions, GLP-1 copies
Inspectors visited the Houston site in November 2025 and said sterile products could be contaminated with filth or rendered injurious to health.
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By Daniel Okafor · Regulatory Correspondent
Sep 24 14:58 ETSource: BioSpace
The wire
- 01The FDA's Sept. 18 letter says Empower Clinic Services compounded tirzepatide and semaglutide products that appear to be essentially copies of approved drugs, and held sterile products under insanitary conditions.
- 02Prescriber determinations of significant difference appeared repeated verbatim across records and were generated through third-party platforms with pre-selected menu options, the agency said.
- 03Empower has 15 working days to respond in writing and, as of Sept. 24, still lists tirzepatide and semaglutide products for sale on its website.
From the source
Read at biospace.comFDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’
The FDA has sent Empower Clinic Services a warning letter detailing failures to comply with rules on drug compounding.
