# FDA 483 - Grand River Aseptic Manufacturing Inc. - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/grand-river-aseptic-manufacturing-inc/fb6a3df3-32ea-495b-ba7d-751d65e86847

> FDA 483 for Grand River Aseptic Manufacturing Inc. on September 29, 2023. 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: 2023-09-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Grand River Aseptic Manufacturing in Caledonia, MI, was cited for failing to establish adequate control procedures for monitoring manufacturing processes. The inspection revealed significant deficiencies in the visual inspection training and qualification for PSMA-11 vials, including the use of insufficient virtual kits and non-representative inspection setups. Additionally, the firm lacked a scientifically sound rationale for setting initial visual inspection defect reject limits and for the required number of batches before updating these limits.

## Related Documents

- [483 - 2025-11-04](https://www.globalkeysolutions.net/records/483/grand-river-aseptic-manufacturing-inc/acb3c5fa-daa3-4fa8-9abf-be9a6d2fae4f)

## 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/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0