Leslie Nguyen, R.Ph. PharmD
Director of Pharmacy
Central Admixture Pharmacy Services, Inc.
7935 Dunbrook Road Ste C
San Diego , CA 92126-6322
United StatesFEI 3009590582Issued Jul 10, 2024Division of Pharmaceutical Quality Operations IV
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.
Violations13
Issue DateJul 10, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Central Admixture Pharmacy Services, Inc.
Location
Leslie Nguyen, R.Ph. PharmD
Director of Pharmacy
Central Admixture Pharmacy Services, Inc.
7935 Dunbrook Road Ste C
San Diego , CA 92126-6322
United States
FEI Number
3009590582
Country
United States
Issue Date
July 10, 2024
Issuing Office
Division of Pharmaceutical Quality Operations IV
Product Type
Drugs
Status
Open
Summary
Central Admixture Pharmacy Services, Inc., a registered outsourcing pharmacy, produced sterile drug products that failed to meet the conditions required under FDA regulations for compounding facility exemptions, resulting in a loss of sterility assurance. FDA investigators identified serious deficiencies in the facility's practices for producing sterile drugs during an inspection from July to August 2023, putting patients at risk and resulting in the company's de-registration in October 2023. The company initiated voluntary recalls of sterile drug products in July and September 2023 and subsequently decided to permanently cease operations at its San Diego location as of November 2023.
Central Admixture Pharmacy Services, Inc. FDA Warning Letter, July 10, 2024
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