FDA Inspection 794818 — Raca Enterprises, Inc. dba Life Cycle Herbal Products
The FDA completed an inspection of Raca Enterprises, Inc. dba Life Cycle Herbal Products on August 20, 2012 in El Monte, CA. 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
- August 20, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- El Monte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15383 | 21 CFR 111.10(a) | Personnel - health condition |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15611 | 21 CFR 111.165(d)(2) | Product received - unique identifier, disposition |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |