FDA Inspection 587663 — Fruit Of The Earth, Inc.
The FDA completed an inspection of Fruit Of The Earth, Inc. on May 29, 2009 in Grand Prairie, TX. 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (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 |