Woodstock Sterile Solutions IncMarch 22, 2022

FDA 483 - Woodstock Sterile Solutions Inc - March 22, 2022

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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.

Company: Woodstock Sterile Solutions Inc
Inspection Date: March 22, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Wendy Tan (Microbiologist)
Wendy Guat Hoon Tan (investigator)

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ID · d62a14f9-b6ba-4974-9c87-888cd9a28a47