FDA Inspection 1047160 — Bell Pharmaceuticals, Inc
The FDA completed an inspection of Bell Pharmaceuticals, Inc on Apr 6, 2018 in Belle Plaine, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Belle Plaine, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |