FDA Inspection 1196614 — Elemental Herbs, Inc.
The FDA completed an inspection of Elemental Herbs, Inc. on February 3, 2023 in Morro Bay, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 3, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morro Bay, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |