FDA Inspection 903229 — Jenara Group, Inc.
The FDA completed an inspection of Jenara Group, Inc. on Nov 14, 2014 in Pacoima, CA. 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). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 14, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Pacoima, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1406 | 21 CFR 110.10(b)(6) | Effective use of hair restraint |
| 15400 | 21 CFR 111.12(a) | Personnel - qualified - general |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 986 | 21 CFR 110.10(b)(2) | Personal cleanliness |