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

Source: https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/d62a14f9-b6ba-4974-9c87-888cd9a28a47

> FDA 483 for Woodstock Sterile Solutions Inc on March 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Woodstock Sterile Solutions Inc
- Inspection Date: 2022-03-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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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## Related Officers

- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [investigator](https://www.keypedia.com/people/wendy-guat-hoon-tan/c7353462-1299-46ae-a4b0-d832d870263d)

Company: https://www.keypedia.com/companies/woodstock-sterile-solutions-inc/c74552f5-448f-41b6-80db-4a6c566f5944

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd