FDA Inspection
Eniva USA, Inc.Eniva USA, Inc. – FDA Inspection, Jan 13, 2025
Record Details
This FDA Inspection record concerns Eniva USA, Inc., with an inspection on January 13, 2025, issued by the Center for Food Safety and Applied Nutrition, covering foods & cosmetics.
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ID · ee53c8fe-2add-40e7-9799-4cadcc4a80c1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1258323
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
FDA Citations
11- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 114.83Scheduled process establishment
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.255(c)Batch record - follow master
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
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Other FDA inspections of Eniva USA, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2026 | Not classified | Minneapolis District Office | Food Composition, Standards, Labeling and Econ |
| August 31, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 6, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 18, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 16, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Eniva USA, Inc.
- FDA Inspection 1333036 - 2026-08-26
- FDA Inspection 1178616 - 2022-08-31
- FDA Inspection 1065627 - 2018-08-06
- FDA Inspection 1023031 - 2017-08-18
- FDA Inspection 933553 - 2015-07-16
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