FDA Inspection 1263502 — Shakti Group, USA, LLC
The FDA completed an inspection of Shakti Group, USA, LLC on September 8, 2025 in Hamilton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Hamilton, NJ (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18272 | 21 CFR 1.504(d) | Document review entity's hazard analysis |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18283 | 21 CFR 1.505(b) | Supplier approval - document |
| 18290 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 18293 | 21 CFR 1.506(b) | Supplier verification - establish written procedures |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |
| 18324 | 21 CFR 1.508(a) | Corrective actions - take, document |
| 18325 | 21 CFR 1.508(b) | Investigate |