FDA Inspection 1221697 — Natren Inc.
The FDA completed an inspection of Natren Inc. on November 2, 2023 in Thousand Oaks, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |