FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
read at BioSpace ↗RegulatoryNegative
FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site.
Inspectors observed that the pharmacy was preparing sterile GLP-1 products, specifically tirzepatide and semaglutide, in quantities that appear to be copies of commercially marketed drugs, violating Section 503A of the FD&C Act.
The agency said the conditions could lead to products being contaminated with filth or otherwise harmful to health, prompting the warning letter and highlighting regulatory non-compliance.
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This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’”
read at BioSpace ↗552 words · retrieved 1h ago
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