FDA Inspection 1086064 — Nutrix International LLC
The FDA completed an inspection of Nutrix International LLC on Apr 11, 2019 in Salt Lake City, UT. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 11, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |