FDA Inspection 1016230 — Bell International Laboratories, Inc.
The FDA completed an inspection of Bell International Laboratories, Inc. on Jun 22, 2017 in Eagan, MN. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |