FDA Inspection 958333 — Raca Enterprises, Inc. dba Life Cycle Herbal Products
The FDA completed an inspection of Raca Enterprises, Inc. dba Life Cycle Herbal Products on January 22, 2016 in El Monte, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 22, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- El Monte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15724 | 21 CFR 111.365(h) | Mechanical steps - contamination |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16050 | 21 CFR 111.525(a) | Returned dietary supplement - specifications |