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Grand River Aseptic Manufacturing — Grand Rapids

Grand Rapids, Michigan, United States · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Grand River Aseptic Manufacturing
Name(s) in FDA data
Grand River Aseptic Manufacturing, Inc.
FEI number(s)
3008716173 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Grand Rapids, Michigan, United States 49504
Records matched
7 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
04 Nov 2025 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …tridge Filling Liquid & Lyophilized Vials Manufacturing Sites The Latest From Grand River Aseptic Manufacturing News CDMO Scale-Up Playbook: De-Risking Commercial Supply An aseptic manufacturing CDM…
  • Lyophilization
    …PFS & Cartridge Filling Liquid & Lyophilized Vials Manufacturing Sites The Latest From Grand River Aseptic Manufacturing News CDMO S…
  • Small molecule
    …ll-Finish Aseptic Manufacturing Facilities Aseptic manufacturing experience in biologics, small molecules, and vaccines is backed by Annex 1 compliant equipment and facilities. Manufacturing Faci…

Taken from a company-level page; the company does not publish a separate page for this site, so tags may describe the wider organisation. Source: https://www.grandriverasepticmfg.com/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 04 Nov 2025
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3008716173, inspection ID 1293364)

  2. 04 Nov 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 1293364)

  3. 21 Feb 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 1233170)

  4. 02 Jul 2021
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 1145269)

  5. 20 Jun 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 1060743)

  6. 03 Dec 2015
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 955644)

  7. 24 Nov 2014
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.63: Equipment Design, Size and Location

    Source: FDA Data Dashboard – Citations (FEI 3008716173, inspection ID 904415)

  8. 24 Nov 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 904415)

  9. 28 Aug 2013
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 846300)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.