# FDA 483 - Woodstock Sterile Solutions Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/woodstock-sterile-solutions-inc/ffd0020d-9317-417d-b8da-14754f091811

> FDA 483 for Woodstock Sterile Solutions Inc on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Woodstock Sterile Solutions Inc
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Woodstock Sterile Solutions received a Form 483 with seven observations during an inspection from May 24-28, 2021, highlighting significant deficiencies in their manufacturing operations. Key issues include inadequate cleaning validation for multi-product equipment, insufficient computer system controls, and a lack of proper cross-contamination prevention for potent and biologic drug products. The report also cited failures in documentation, raw material release, equipment logbook completeness, and microbiological testing procedures.

## Related Documents

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

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/milva-melendez/164c3147-2aea-4d81-b55c-d139eab17ea4)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321