The FDA has issued a warning letter to Houston-based Empower Pharmacy after an inspection found evidence that certain compounded drugs failed to meet conditions for exemptions under federal law.
The agency said Empower compounded products that appeared to be essentially copies of FDA-approved semaglutide and tirzepatide products “regularly and in inordinate amounts,” according to the Sept. 18 warning letter. FDA investigators also cited insanitary conditions and current good manufacturing practice violations.
Among the issues, investigators said Empower failed to perform adequate smoke studies under dynamic conditions and its media fills were not performed under the most challenging or stressful conditions. The FDA also cited deficiencies involving aseptic processing, environmental monitoring, quality control and production procedures.
The FDA said some corrective actions appeared adequate, others could not be fully evaluated and others appeared deficient. The agency directed Empower to respond within 15 working days and said failure to adequately address the violations may result in legal action, including seizure and injunction.
