FDA Inspection 1114559 — Resveratrol, Inc. dba NutraGrape Inc
The FDA completed an inspection of Resveratrol, Inc. dba NutraGrape Inc on January 8, 2020 in Rose Hill, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rose Hill, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15397 | 21 CFR 111.10(b)(7) | Personal belongings |
| 15411 | 21 CFR 111.14(b)(2) | Personnel - records - training date, type, persons |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15500 | 21 CFR 111.27(a)(2) | Equipment - design - no contamination |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |