# FDA 483 - Woodstock Sterile Solutions Inc - June 25, 2019

Source: https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/bf654947-1416-46c9-851a-83106f9ade82

> FDA 483 for Woodstock Sterile Solutions Inc on June 25, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Woodstock Sterile Solutions Inc
- Inspection Date: 2019-06-25
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Catalent Pharma Solutions, LLC in Woodstock, IL, a drug product manufacturer, revealed several significant deficiencies. These included inadequate environmental monitoring, failure to follow standard operating procedures, an insufficient visual inspection process, poorly maintained utilities and equipment, and an inadequate production batch record for yield discrepancies. The findings indicate a need for improved control over critical manufacturing and quality processes.

## Related Documents

- [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)
- [483 - 2025-09-23](https://www.keypedia.com/records/483/woodstock-sterile-solutions-inc/90fae064-c666-4d6f-8735-a2655ac45e74)

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [issuing_officer](https://www.keypedia.com/people/amy-a-devlin/fed31d2d-96d0-4849-a167-92bec5d6d2be)

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