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FDA Inspection
•Exclusive Supplements, Inc.•March 21, 2013

Exclusive Supplements, Inc. – FDA Inspection, Mar 21, 2013

Record Details

This FDA Inspection record concerns Exclusive Supplements, Inc., with an inspection on March 21, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Exclusive Supplements, Inc.
Inspection Date
March 21, 2013
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · e886fc1d-f0b2-4abe-9267-07461a2b14d5

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
824381
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

14
  1. 21 CFR 111.560(a)(2)Product complaint - quality control investigate
  2. No AE report made (dietary supplement)
  3. 21 CFR 111.12Personnel - quality control personnel - qualified
  4. 21 CFR 111.83(a)Reserve sample - collect, hold
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.70(f)Specifications - product received for packaging, labeling
  7. 21 CFR 111.553Written procedures - product complaint
  8. 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
  9. 21 CFR 111.205(a)Master manufacturing record - unique formulation
  10. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier

Showing 10 of 14 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Exclusive Supplements, Inc.

3
DateClassificationOfficeProject area
November 18, 2015NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 16, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 8, 2010NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Exclusive Supplements, Inc.
  • FDA Inspection 951958 - 2015-11-18
  • FDA Inspection 892995 - 2014-09-16
  • FDA Inspection 697940 - 2010-11-08

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