FDA Inspection 955992 — Bell Pharmaceuticals, Inc
The FDA completed an inspection of Bell Pharmaceuticals, Inc on Nov 20, 2015 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 20, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Belle Plaine, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |