FDA Inspection
Trace Herbals LLCTrace Herbals LLC – FDA Inspection, Sep 3, 2021
Record Details
This FDA Inspection record concerns Trace Herbals LLC, with an inspection on September 3, 2021, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Trace Herbals LLC
- Inspection Date
- September 3, 2021
- Product Type
- Food/cosmetics
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ID · ad8b9b29-57d7-453e-825c-90c99d22781b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1150579
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
12- 21 CFR 111.560(a)(2)Product complaint - quality control investigate
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.25Equipment - procedures
- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.365(h)Mechanical steps - contamination
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of Trace Herbals LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 11, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 26, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 14, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 12, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Trace Herbals LLC
- FDA Inspection 1240653 - 2024-06-07
- FDA Inspection 1068430 - 2018-09-11
- FDA Inspection 1003435 - 2016-10-26
- FDA Inspection 860873 - 2014-01-14
- FDA Inspection 791034 - 2012-07-12
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