# Grand River Aseptic Manufacturing, Inc. – FDA 483, Jun 5, 2026

Source: https://www.keypedia.com/records/483/grand-river-aseptic-manufacturing-inc/b91154c3-6ed8-4f12-b417-8137cd31b1a4

> FDA 483 for Grand River Aseptic Manufacturing, Inc. on June 05, 2026. 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: 2026-06-05
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, a pharmaceutical drug manufacturer, was cited for three observations during an FDA inspection. The issues include failures in investigating unexplained discrepancies in batch records, inadequate routine inspection and maintenance of equipment leading to recurring issues, and non-adherence to aseptic procedures during sterile drug product manufacturing. These findings indicate significant concerns regarding quality control, equipment reliability, and contamination prevention practices.

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- [EIR - 2021-07-02](https://www.keypedia.com/records/eir/grand-river-aseptic-manufacturing-inc/291ba804-db78-44cb-a5b1-6bb343da8b7b) — date: July 2, 2021

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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