FDA Inspection 1195851 — Herbal Essentials Inc.
The FDA completed an inspection of Herbal Essentials Inc. on Jan 30, 2023 in Edison, NJ. 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15574 | 21 CFR 111.153 | Written procedures - rejected components, packaging, labels |
| 15575 | 21 CFR 111.153 | Written procedures - rejected products |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |