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FDA Inspection
•Confidence U.S.A. Inc.•January 12, 2017

Confidence U.S.A. Inc. – FDA Inspection, Jan 12, 2017

Record Details

This FDA Inspection record concerns Confidence U.S.A. Inc., with an inspection on January 12, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Confidence U.S.A. Inc.
Inspection Date
January 12, 2017
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
People
  • Jay T. Wong (Issuing Officer)
  • Meredith P. Soehl (FDA Associated Person)
View Company Profile

ID · 305b4180-6ff5-4957-8fc1-9a3a23ebf4de

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
997649
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

7
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  3. 21 CFR 111.255(a)Batch record - every batch
  4. 21 CFR 111.205(a)Master manufacturing record - each batch
  5. 21 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.75(c)Specifications met - verify; finished batch

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Confidence U.S.A. Inc.

9
DateClassificationOfficeProject area
October 22, 2024Not classifiedNew York District OfficeFood Composition, Standards, Labeling, and Economics
August 20, 2021NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
August 10, 2018OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
April 12, 2016OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
July 13, 2012OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 9 other inspections on the company page
Other documents for Confidence U.S.A. Inc.
  • FDA Inspection 1242510 - 2024-10-22
  • FDA Inspection 1149518 - 2021-08-20
  • FDA Inspection 1062626 - 2018-08-10
  • FDA Inspection 966213 - 2016-04-12
  • FDA Inspection 790126 - 2012-07-13

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
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201 Lackawanna Avenue
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