FDA Inspection 826998 — Bell Pharmaceuticals, Inc
The FDA completed an inspection of Bell Pharmaceuticals, Inc on Apr 5, 2013 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 5, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Belle Plaine, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 8935 | FDCA 760(b)(1) | Failure of responsible person to report AE (non-RX Drug) |