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FDA Inspection
•Anatox Inc•September 2, 2022

Anatox Inc – FDA Inspection, Sep 2, 2022

Record Details

This FDA Inspection record concerns Anatox Inc, with an inspection on September 2, 2022, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Anatox Inc
Inspection Date
September 2, 2022
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 89531f31-6124-4e67-8e98-41bde708f9ad

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1178837
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

14
  1. 21 CFR 111.12Personnel - quality control personnel - qualified
  2. 21 CFR 111.70(b)(1)Specifications - component identity
  3. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  4. 21 CFR 111.70(b)(3)Specifications - contamination limits
  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 111.25(a)Procedures - calibrating instruments
  8. 21 CFR 111.205(a)Master manufacturing record - each batch
  9. 21 CFR 111.255(b)Batch record - complete
  10. 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality

Showing 10 of 14 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Anatox Inc

7
DateClassificationOfficeProject area
April 17, 2023VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 20, 2018VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 13, 2017OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 14, 2016OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 5, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 7 other inspections on the company page
Other documents for Anatox Inc
  • FDA Inspection 1202731 - 2023-04-17
  • FDA Inspection 1066149 - 2018-09-20
  • FDA Inspection 1028597 - 2017-10-13
  • FDA Inspection 985223 - 2016-09-14
  • FDA Inspection 917320 - 2015-03-05

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Scranton Office:
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