FDA Inspection 1257112 — Elemental Herbs, Inc.
The FDA completed an inspection of Elemental Herbs, Inc. on Dec 20, 2024 in Morro Bay, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 20, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morro Bay, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |