# Woodstock Sterile Solutions Inc – FDA 483, Jun 9, 2026

Source: https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/a526b77c-cbda-4b13-9da5-44b662a63b72

> FDA 483 for Woodstock Sterile Solutions Inc on June 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Woodstock Sterile Solutions Inc
- Inspection Date: 2026-06-09
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Woodstock Sterile Solutions Inc, a human drug manufacturer in Woodstock, IL, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control, including inadequate raw material testing, failures in aseptic processing procedures and environmental monitoring, and a lack of thorough investigations into discrepancies and product complaints. Additionally, the firm's leadership and production staff demonstrated insufficient training in critical areas like smoke study methodology, risk assessment, and cleaning techniques.

## Related Documents

- [483 - 2025-09-23](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/90fae064-c666-4d6f-8735-a2655ac45e74) — date: September 23, 2025
- [483 - 2022-03-22](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/d62a14f9-b6ba-4974-9c87-888cd9a28a47) — date: March 22, 2022
- [EIR - 2021-05-28](https://www.keypedia.com/records/eir/woodstock-sterile-solutions-inc/a32511cc-d554-43e9-922f-8f92fd3a8e09) — date: May 28, 2021
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- [EIR - 2019-05-23](https://www.keypedia.com/records/eir/woodstock-sterile-solutions-inc/90fb5267-afb0-40d9-929c-c383a8e43d2b) — date: May 23, 2019

## Related Officers

- [Tyler M. Peterson](https://www.keypedia.com/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [investigator](https://www.keypedia.com/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669