FDA Inspection
Grand River Aseptic Manufacturing Inc.Grand River Aseptic Manufacturing Inc. – FDA Inspection, Nov 4, 2025
Record Details
This FDA Inspection record concerns Grand River Aseptic Manufacturing Inc., with an inspection on November 4, 2025, issued by the Detroit District Office, covering human drugs.
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ID · 508b1f53-f3ac-42d4-b505-f60b05439e55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1293366
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
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Other FDA inspections of Grand River Aseptic Manufacturing Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2024 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 29, 2023 | VAI | Detroit District Office |
Other documents for Grand River Aseptic Manufacturing Inc.
- FDA Inspection 1236900 - 2024-02-21
- FDA Inspection 1219116 - 2023-09-29
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