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FDA Inspection
•RegenX, LLC•September 20, 2023

RegenX, LLC – FDA Inspection, Sep 20, 2023

Record Details

This FDA Inspection record concerns RegenX, LLC, with an inspection on September 20, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
RegenX, LLC
Inspection Date
September 20, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Jesse P. Romenesko (Company Rep)
View Company Profile

ID · c6c2e1c0-eb11-42b7-917d-f077ce741bd2

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1218238
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 111.103Written procedures - quality control operations
  2. 21 CFR 111.415(g)Representative sample - packaged, labeled dietary supplement
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  4. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  5. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier

Full citation text and observation details available on the Dashboard.

Other FDA inspections of RegenX, LLC

2
DateClassificationOfficeProject area
November 6, 2024VAIMinneapolis District OfficeColors and Cosmetics Technology
August 24, 2022VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for RegenX, LLC
  • FDA Inspection 1253912 - 2024-11-06
  • FDA Inspection 1178342 - 2022-08-24

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