FDA Inspection 1254540 — Holi Hemp LLC
The FDA completed an inspection of Holi Hemp LLC on November 19, 2024 in Vancouver, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |