483
Woodstock Sterile Solutions IncWoodstock Sterile Solutions Inc – FDA 483, Mar 22, 2022
Record Details
Woodstock Sterile Solutions, Inc. in Woodstock, IL, a drug product manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to adequately investigate recurring environmental monitoring excursions, specifically mold recoveries exceeding limits. Additionally, the inspection revealed a lack of contemporaneous verification for bioburden test results, raising concerns about data integrity in the QC Microbiology Laboratory.
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ID · d62a14f9-b6ba-4974-9c87-888cd9a28a47
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