FDA Inspection 856746 — Fruit Of The Earth, Inc.
The FDA completed an inspection of Fruit Of The Earth, Inc. on January 30, 2014 in Grand Prairie, TX. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |