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FDA Inspection
•Eniva USA, Inc.•August 26, 2026

Eniva USA, Inc. – FDA Inspection, Aug 26, 2026

Record Details

This FDA Inspection record concerns Eniva USA, Inc., with an inspection on August 26, 2026, issued by the Minneapolis District Office, covering foods & cosmetics.

Company
Eniva USA, Inc.
Inspection Date
August 26, 2026
Product Type
Foods & Cosmetics
Office
Minneapolis District Office
People
  • Courtney R. Ingalsbe (Issuing Officer)
  • Rebecca L. Keller (Issuing Officer)
View Company Profile

ID · c5f3ac34-c8af-4d19-b901-39f4bb3739c1

Inspection Facts

Inspection number
1333036
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

13
  1. 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
  2. 21 CFR 111.27(b)Instruments - calibration
  3. 21 CFR 111.320(a)Examination, testing; appropriate
  4. 21 CFR 111.320(b)Examination, testing; scientifically valid
  5. 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
  6. 21 CFR 111.610(a)Records - available; FDA
  7. 21 CFR 111.70(b)Specifications - components
  8. 21 CFR 111.70(e)Specifications - finished dietary supplement
  9. 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
  10. 21 CFR 111.75(a)(2)(ii)(D)Re-confirm certificate of analysis

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Eniva USA, Inc.

8
DateClassificationOfficeProject area
January 13, 2025OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling, and Economics
August 31, 2022VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 6, 2018NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 18, 2017VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
July 16, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 8 other inspections on the company page
Other documents for Eniva USA, Inc.
  • FDA Inspection 1258323 - 2025-01-13
  • 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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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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