FDA Inspection 1272867 — Grant Industries, Inc.
The FDA completed an inspection of Grant Industries, Inc. on June 16, 2025 in Elmwood Park, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Elmwood Park, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |