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FDA Inspection
•Avena Botanicals, LLC•May 30, 2014

Avena Botanicals, LLC – FDA Inspection, May 30, 2014

Record Details

This FDA Inspection record concerns Avena Botanicals, LLC, with an inspection on May 30, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Avena Botanicals, LLC
Inspection Date
May 30, 2014
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 9dfc88eb-1424-414c-8df8-d9276e550208

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
882078
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

13
  1. 21 CFR 111.210(h)(5)Corrective action plans
  2. 21 CFR 111.210(h)(3)(i)Components, verify weight, measure
  3. 21 CFR 111.210(h)(1)Instructions; specifications; packaged, labeled
  4. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  5. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  6. 21 CFR 111.70(b)(3)Specifications - contamination limits
  7. 21 CFR 111.475(b)(1)Written procedures - holding; distributing
  8. 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
  9. 21 CFR 111.255(c)Batch record - each step
  10. 21 CFR 111.205(a)Master manufacturing record - each batch

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Avena Botanicals, LLC

5
DateClassificationOfficeProject area
June 30, 2023NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
November 14, 2017NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 28, 2016VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 18, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
May 19, 2011VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Avena Botanicals, LLC
  • FDA Inspection 1215170 - 2023-06-30
  • FDA Inspection 1032407 - 2017-11-14
  • FDA Inspection 980581 - 2016-06-28
  • FDA Inspection 934621 - 2015-06-18
  • FDA Inspection 729292 - 2011-05-19

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