FDA Inspection 1293366 — Grand River Aseptic Manufacturing Inc.
The FDA completed an inspection of Grand River Aseptic Manufacturing Inc. on November 4, 2025 in Caledonia, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caledonia, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |