FDA Inspection 582576 — Bell Pharmaceuticals, Inc
The FDA completed an inspection of Bell Pharmaceuticals, Inc on May 15, 2009 in Belle Plaine, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Belle Plaine, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |