FDA Inspection 848592 — Raca Enterprises, Inc. dba Life Cycle Herbal Products
The FDA completed an inspection of Raca Enterprises, Inc. dba Life Cycle Herbal Products on September 23, 2013 in El Monte, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 23, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- El Monte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15850 | 21 CFR 111.73 | Specifications met in-process purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |
| 15981 | 21 CFR 111.123(a)(5) | Quality control operations - reprocessing |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |