FDA Inspection 760595 — Fruit Of The Earth, Inc.
The FDA completed an inspection of Fruit Of The Earth, Inc. on January 3, 2012 in Grand Prairie, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 3, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |