FDA Inspection 1263661 — Chae Organics LLC
The FDA completed an inspection of Chae Organics LLC on Mar 14, 2025 in Walsenburg, CO. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Walsenburg, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |