760595
Fruit Of The Earth, Inc. — FEI 1420298
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 |