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FDA Inspection
•Norax Supplements LLC•August 26, 2016

FDA Inspection 983503 - Norax Supplements LLC - August 26, 2016

Record Details

This FDA Inspection record concerns Norax Supplements LLC, with an inspection on August 26, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Norax Supplements LLC
Inspection Date
August 26, 2016
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · c2496dc2-2969-4661-990a-6d0b322fb2cf

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
983503
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

13
  1. 21 CFR 111.12(c)Personnel - education, training, experience
  2. 21 CFR 111.15(e)(2)Water supply - may be component - suitability
  3. 21 CFR 111.205(a)Master manufacturing record - each batch
  4. 21 CFR 111.455(a)Hold - temperature, humidity, light
  5. 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.365(i)Metal, foreign material
  8. 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
  9. 21 CFR 111.255(b)Batch record - complete
  10. 21 CFR 111.260(l)(4)Batch record - approved, released, rejected

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Norax Supplements LLC

3
DateClassificationOfficeProject area
April 18, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 23, 2018OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 10, 2016VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Norax Supplements LLC
  • FDA Inspection 1087574 - 2019-04-18
  • FDA Inspection 1041977 - 2018-02-23
  • FDA Inspection 969091 - 2016-03-10

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