Ms. Rachel C. Schwartz
Director of Pharmacy
Central Admixture Pharmacy Services, Inc.
6580 Snowdrift Road Suite 100
Allentown , PA 18106-9331
United StatesFEI 3009590582Issued Mar 29, 2024Division of Pharmaceutical Quality Operations I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009590582.
Violations3
Issue DateMar 29, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Central Admixture Pharmacy Services, Inc.
Location
Ms. Rachel C. Schwartz
Director of Pharmacy
Central Admixture Pharmacy Services, Inc.
6580 Snowdrift Road Suite 100
Allentown , PA 18106-9331
United States
FEI Number
3009590582
Country
United States
Issue Date
March 29, 2024
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Open
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.
Central Admixture Pharmacy Services, Inc. FDA Warning Letter, March 29, 2024
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