587663
Fruit Of The Earth, Inc. — FEI 1420298
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Prairie, TX (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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |