FDA Inspection
Evimeria El Aztecano, Inc.Evimeria El Aztecano, Inc. – FDA Inspection, Apr 28, 2023
Record Details
This FDA Inspection record concerns Evimeria El Aztecano, Inc., with an inspection on April 28, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 7ef923ae-364e-4bba-b4f6-24462a95f5f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204034
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 111.12Personnel - quality control personnel - qualified
- 21 CFR 111.210(h)(1)Instructions; specifications; quality
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.95(b)(2)Documentation - supplier qualification
- 21 CFR 111.12Personnel - quality control personnel - qualified
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Other FDA inspections of Evimeria El Aztecano, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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