FDA Inspection 1132017 — Auri Nutra, Inc.
The FDA completed an inspection of Auri Nutra, Inc. on Oct 21, 2020 in Farmingdale, NY. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2020
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |