FDA Inspection 1155766 — Nutriventus, Inc.
The FDA completed an inspection of Nutriventus, Inc. on Nov 2, 2021 in East Berlin, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 2, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- East Berlin, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15866 | 21 CFR 111.75(a)(2)(ii)(E) | Documentation - quality control, review, approve supplier |
| 15948 | 21 CFR 111.110 | Quality control operations - laboratory operations |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |