FDA Inspection 1150579 — Trace Herbals LLC
The FDA completed an inspection of Trace Herbals LLC on September 3, 2021 in Santa Fe, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Santa Fe, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15724 | 21 CFR 111.365(h) | Mechanical steps - contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |