# FDA EIR - Grand River Aseptic Manufacturing, Inc. - July 02, 2021

Source: https://www.keypedia.com/records/eir/grand-river-aseptic-manufacturing-inc/291ba804-db78-44cb-a5b1-6bb343da8b7b

> FDA EIR for Grand River Aseptic Manufacturing, Inc. on July 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Grand River Aseptic Manufacturing, Inc.
- Inspection Date: 2021-07-02
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Grand River Aseptic Manufacturing, Inc. (GRAM) underwent a preannounced surveillance and preapproval inspection by the FDA from June 15 to July 2, 2021, at its Grand Rapids, MI facility. This inspection, conducted under Compliance Programs 7346.832 and 7356.002A, focused on the company’s adherence to current Good Manufacturing Practices (cGMP) for sterile pharmaceuticals, including an application for a PET drug kit. The inspection covered quality, materials, production, and laboratory systems.

## Related Documents

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## Related Officers

- [company_representative](https://www.keypedia.com/people/jennifer-leale/00f66020-524d-40c2-8cf2-aca92c1a5e2d)
- [company_representative](https://www.keypedia.com/people/michael-kane/182154bb-e4f1-43b0-b048-39d2987169ac)
- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [company_representative](https://www.keypedia.com/people/dennis-graber/5bb55adc-ba0a-4ae7-815f-ab8ef9e2d692)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

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