FDA Inspection 629990 — B & G Labs, Inc
The FDA completed an inspection of B & G Labs, Inc on November 24, 2009 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 24, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |