FDA Inspection 1061594 — Four Elements Organic Herbals, LLC
The FDA completed an inspection of Four Elements Organic Herbals, LLC on August 9, 2018 in North Freedom, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 28 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 9, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- North Freedom, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 1005 | 21 CFR 110.10(b)(7) | Storage of personal items |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 1601 | 21 CFR 110.37(a) | Safe and adequate sanitary quality |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 16065 | 21 CFR 111.35(b)(1) | Written procedures - equipment, utensils; make, keep |
| 16494 | FDCA 601(c) | Insanitary conditions; contaminated with filth |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 3647 | 21 CFR 110.10(c) | Training of handlers and supervisors |
| 3657 | 21 CFR 110.37(d)(4) | Doors opening into processing areas |
| 3660 | 21 CFR 110.37(e)(4) | Devices and fixtures |