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

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Record Details

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.

Company: Grand River Aseptic Manufacturing, Inc.
Inspection Date: July 2, 2021
Product Type: Drugs
Office: Detroit District Office
People: Jennifer Leale (company_representative)
Michael Kane (company_representative)
Joseph A. Piechocki
Dennis Graber (company_representative)
Lisa R. Hilliard (Consumer Safety Officer , Investigator)

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ID · 291ba804-db78-44cb-a5b1-6bb343da8b7b

Violation Codes10

21 CFR 211.5821 CFR 211.160(b)21 CFR 211.110(a)21.U.S.C. 355(a)21 CFR 21121 CFR 211.67(a)21 CFR 211.22(a)21 CFR 211.80(a)21 CFR 820.5021 CFR 211.42(c)(10)(vi)

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