# FDA 483 - Woodstock Sterile Solutions Inc - September 23, 2025

Source: https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/90fae064-c666-4d6f-8735-a2655ac45e74

> FDA 483 for Woodstock Sterile Solutions Inc on September 23, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Woodstock Sterile Solutions Inc
- Inspection Date: 2025-09-23
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Woodstock Sterile Solutions Inc. in Woodstock, IL, a drug manufacturer, received a Form 483 with three observations highlighting significant deficiencies. The firm failed to establish adequate production and process controls, lacked proper procedures to prevent microbiological contamination of sterile products, and had deficient calibration procedures for critical manufacturing equipment. These issues collectively indicate a lack of control over product quality, sterility, and process reproducibility.

## Related Documents

- [483 - 2019-06-25](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/bf654947-1416-46c9-851a-83106f9ade82)
- [483 - Unknown Date](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/ffd0020d-9317-417d-b8da-14754f091811)
- [483 - 2022-03-22](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/d62a14f9-b6ba-4974-9c87-888cd9a28a47)
- [483 - 2022-03-03](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/391443c0-af5b-4fc8-bfd5-283ab0d1903b)
- [483 - 2025-09-23](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/571dc36f-b2c5-4ae5-b448-f8aacdbf71b1)

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

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