# FDA 483 - Grand River Aseptic Manufacturing, Inc. - July 02, 2021

Source: https://www.globalkeysolutions.net/records/483/grand-river-aseptic-manufacturing-inc/6e70f952-4812-49d1-8dae-c3586a96a040

> FDA 483 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: 483
- Company Name: Grand River Aseptic Manufacturing, Inc.
- Inspection Date: 2021-07-02
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, revealed multiple deficiencies across its quality, production, laboratory, materials, and facilities systems. Key issues included inadequate investigations into out-of-specification results, failure to adhere to standard operating procedures for visual inspection kits and balance operations, and a lack of appropriate specifications for drug products. The firm also failed to follow procedures for material handling and expiration, maintained deficient aseptic processing areas, and had buildings and equipment in disrepair.

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## Related Officers

- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)
- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0