Central Admixture Pharmacy Services, Inc. Warning Letter Details

Summary

Central Admixture Pharmacy Services, Inc., an outsourcing facility registered to compound sterile drug products, was cited for serious deficiencies in practices for producing drugs intended to be sterile that put patients at risk. During an FDA inspection conducted from February 27 to March 30, 2023, investigators documented violations of current Good Manufacturing Practice (CGMP) requirements under the Federal Food, Drug, and Cosmetic Act. The facility initiated a voluntary recall on April 28, 2023, of sterile drug products within expiry due to lack of sterility assurance, indicating the compounded drugs violated FDCA requirements.