# FDA 483 - Woodstock Sterile Solutions Inc - March 03, 2022

Source: https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/391443c0-af5b-4fc8-bfd5-283ab0d1903b

> FDA 483 for Woodstock Sterile Solutions Inc on March 03, 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: 2022-03-03
- 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 inspected by the FDA from February 28 to March 3, 2022. The inspection revealed significant issues related to quality control, specifically concerning inadequate investigations into recurring environmental monitoring excursions and a lack of contemporaneous verification for bioburden test results. These findings indicate deficiencies in the firm's quality system and data integrity practices.

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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