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FDA Inspection
•Professional Botanicals, Inc.•October 11, 2016

Professional Botanicals, Inc. – FDA Inspection, Oct 11, 2016

Record Details

This FDA Inspection record concerns Professional Botanicals, Inc., with an inspection on October 11, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Professional Botanicals, Inc.
Inspection Date
October 11, 2016
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Jennifer A. Robinson (Issuing Officer)
View Company Profile

ID · e302a221-353d-4e01-9eae-ec2d5464f4ee

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
988266
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

7
  1. 21 CFR 111.410(b)Labels - issuance, use
  2. 21 CFR 111.73Specifications met - quality
  3. 21 CFR 111.453Written procedures - holding
  4. 21 CFR 111.510Returned dietary supplement - material review, disposition
  5. 21 CFR 111.205(a)Master manufacturing record - unique formulation
  6. 21 CFR 111.255(b)Batch record - complete
  7. 21 CFR 111.14(b)(2)Personnel - records - training date, type, persons

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Professional Botanicals, Inc.

4
DateClassificationOfficeProject area
May 27, 2025VAIDenver District OfficeFood Composition, Standards, Labeling, and Economics
January 22, 2018VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 30, 2013NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 27, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Professional Botanicals, Inc.
  • FDA Inspection 1270895 - 2025-05-27
  • FDA Inspection 1038275 - 2018-01-22
  • FDA Inspection 857856 - 2013-10-30
  • FDA Inspection 821443 - 2013-02-27

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