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

Source: https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/37abd61f-8bd2-44d4-a17b-58712d4812a3

> 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: Detroit District Office
- Summary: An FDA inspection of Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, identified two significant observations. The firm failed to adequately simulate all manufacturing processing steps during a fill validation study for a syringe filling line. Additionally, unplanned operational activities and interventions were not timely documented in manufacturing batch records.

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## 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)
- [Neetu Dahiya](https://www.keypedia.com/people/neetu-dahiya/eca2915a-15a1-4f2b-a32f-99515fdde490)

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