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

Source: https://www.globalkeysolutions.net/records/483/grand-river-aseptic-manufacturing-inc/acb3c5fa-daa3-4fa8-9abf-be9a6d2fae4f

> 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: An FDA inspection of Grand River Aseptic Manufacturing Inc. in Caledonia, MI, revealed significant deficiencies in manufacturing process control and quality unit procedures. Observations included a lack of statistically justified sample sizes for inspection methods and inadequate risk assessments for particulate matter. Additionally, the firm failed to properly document data processing optimization and assess the appropriateness of analyst privileges within their data systems.

## Related Documents

- [483 - 2023-09-29](https://www.globalkeysolutions.net/records/483/grand-river-aseptic-manufacturing-inc/fb6a3df3-32ea-495b-ba7d-751d65e86847)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.globalkeysolutions.net/companies/grand-river-aseptic-manufacturing-inc/f538a5fa-320e-4240-954d-762b7d02795a

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