FDA Inspection 594690 — Bell International Laboratories, Inc.
The FDA completed an inspection of Bell International Laboratories, Inc. on Jul 7, 2009 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 7, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |