FDA 483 - Central Admixture Pharmacy Services, Inc. - September 05, 2025
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An FDA inspection of Central Admixture Pharmacy Services, Inc. in Phoenix, AZ, revealed significant deficiencies in quality control, manufacturing processes, and laboratory operations. The firm failed to thoroughly investigate recurring product defects like particulate matter and leaks, lacked adequate testing for incoming components, and demonstrated issues with sterility testing validation and environmental monitoring. The Quality Unit was found to be ineffective in addressing discrepancies and ensuring product quality.
ID · 16d26675-afb6-402f-8135-824c75c5374e