FDA Inspection 760451 — Natren Inc.
The FDA completed an inspection of Natren Inc. on December 22, 2011 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |