FDA Inspection 1201176 — E&D Herbs Medicine Natural Product, LLC
The FDA completed an inspection of E&D Herbs Medicine Natural Product, LLC on March 28, 2023 in Moca, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Moca, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |