483
Active Creations LLCActive Creations LLC – FDA 483, Nov 2, 2021
Record Details
An FDA inspection of Suite K Value Added Services LLC in Edison, NJ, revealed two significant observations related to manufacturing controls. The firm failed to validate its warehouse management system, impacting critical operations like material receiving and inventory. Additionally, equipment maintenance was found inadequate, with damaged gaskets on manufacturing vessels posing a contamination risk to drug products.
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ID · 5a9f3a1c-0f33-4726-b6fe-155795eeaccf
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