# FDA 483 - Grand River Aseptic Manufacturing, Inc. - November 04, 2025

Source: https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/c365808d-9967-4482-8463-dcf37caed8f3

> FDA 483 for Grand River Aseptic Manufacturing, Inc. on November 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grand River Aseptic Manufacturing, Inc.
- Inspection Date: 2025-11-04
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, was inspected and cited for significant deficiencies in its aseptic process validation, specifically regarding media fills that did not represent typical worst-case conditions or routine production. Additionally, the firm lacked written procedures for its quality control unit, particularly concerning data integration optimization and analyst access privileges, raising concerns about data integrity.

## Related Documents

- [483 - 2021-07-02](https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/6e70f952-4812-49d1-8dae-c3586a96a040)
- [483 - 2024-09-19](https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/37abd61f-8bd2-44d4-a17b-58712d4812a3)

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/grand-river-aseptic-manufacturing-inc/13c89215-d999-4ffa-a212-2ebcf9a6947a

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03