FDA Inspection
Grand River Aseptic Manufacturing, Inc.Grand River Aseptic Manufacturing, Inc. – FDA Inspection, Nov 24, 2014
Record Details
This FDA Inspection record concerns Grand River Aseptic Manufacturing, Inc., with an inspection on November 24, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 24, 2014
- Product Type
- Drugs
View Company Profile
ID · 73b3b3f0-1676-4f65-99a2-7dceb1690e97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904415
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Grand River Aseptic Manufacturing, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Detroit District Office | Vaccines and Allergenic Products |
| 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 |
Other documents for Grand River Aseptic Manufacturing, Inc.
- FDA Inspection 1317294 - 2026-06-05
- FDA Inspection 1293364 - 2025-11-04
- FDA Inspection 1256172 - 2024-09-19
- FDA Inspection 1233170 - 2024-02-21
- FDA Inspection 1145269 - 2021-07-02
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