FDA Inspection
Trace Elements, IncTrace Elements, Inc – FDA Inspection, Jan 19, 2016
Record Details
This FDA Inspection record concerns Trace Elements, Inc, with an inspection on January 19, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Trace Elements, Inc
- Inspection Date
- January 19, 2016
- Product Type
- Food/cosmetics
View Company Profile
ID · 8990e858-4363-4e6b-8de3-6e7b1813a4a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 956270
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.75(e)Product - visually examine, identified
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.127(h)Quality control operations - packaging, labeling; approving, rejecting
- 21 CFR 111.410(d)Manufacturing history
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Other FDA inspections of Trace Elements, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 30, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 6, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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