# FDA 483 - Grand River Aseptic Manufacturing, Inc. - September 19, 2024

Source: https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/eabfb1de-2d52-4c79-bda5-3dbe05d78e5c

> FDA 483 for Grand River Aseptic Manufacturing, Inc. on September 19, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grand River Aseptic Manufacturing, Inc.
- Inspection Date: 2024-09-19
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, was inspected by the FDA from September 16-19, 2024. The inspection revealed issues related to manufacturing process validation and documentation practices. Specifically, a syringe filling line validation study did not simulate all necessary steps, and unplanned activities were not timely documented in batch records.

## Related Documents

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- [483 - 2025-11-04](https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/c365808d-9967-4482-8463-dcf37caed8f3)

## Related Officers

- [investigator](https://www.keypedia.com/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)
- [Nidhi Dahiya](https://www.keypedia.com/people/nidhi-dahiya/a33a79a4-2167-4d18-a4f4-83bd25defcea)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4