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FDA Inspection
•Immune Tree, Inc.•June 2, 2016

Immune Tree, Inc. – FDA Inspection, Jun 2, 2016

Record Details

This FDA Inspection record concerns Immune Tree, Inc., with an inspection on June 2, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Immune Tree, Inc.
Inspection Date
June 2, 2016
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 482711bc-1d14-407f-bb81-2cb909e2f887

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
973926
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

10
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  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(e)Specifications - identity, purity, strength, composition
  5. 21 CFR 111.510Returned dietary supplement - material review, disposition
  6. 21 CFR 111.65Quality control - quality, dietary supplement
  7. 21 CFR 111.205(a)Master manufacturing record - each batch
  8. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  9. 21 CFR 111.75(c)Specifications met - verify; finished batch
  10. 21 CFR 111.255(b)Batch record - complete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Immune Tree, Inc.

3
DateClassificationOfficeProject area
March 25, 2022VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 29, 2018VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 13, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Immune Tree, Inc.
  • FDA Inspection 1165930 - 2022-03-25
  • FDA Inspection 1057646 - 2018-06-29
  • FDA Inspection 822289 - 2013-03-13

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