FDA Inspection
Grand River Aseptic Manufacturing, Inc.Grand River Aseptic Manufacturing, Inc. – FDA Inspection, Jun 5, 2026
Record Details
This FDA Inspection record concerns Grand River Aseptic Manufacturing, Inc., with an inspection on June 5, 2026, issued by the Detroit District Office, covering biologics.
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ID · 7d4d49f5-1697-4056-85b5-d3d462c1d06a
Inspection Facts
- Inspection number
- 1317294
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Grand River Aseptic Manufacturing, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2025 | VAI | Detroit District Office | Drug Quality Assurance |
| September 19, 2024 | Not classified | Detroit District Office | |
| February 21, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 2, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Grand River Aseptic Manufacturing, Inc.
- FDA Inspection 1293364 - 2025-11-04
- FDA Inspection 1256172 - 2024-09-19
- FDA Inspection 1233170 - 2024-02-21
- FDA Inspection 1145269 - 2021-07-02
- FDA Inspection 1060743 - 2018-06-20
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