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FDA Inspection
•The Herbalist Inc•October 23, 2025

FDA Inspection 1288684 - The Herbalist Inc - October 23, 2025

Record Details

This FDA Inspection record concerns The Herbalist Inc, with an inspection on October 23, 2025, issued by the Seattle District Office, covering foods & cosmetics.

Company
The Herbalist Inc
Inspection Date
October 23, 2025
Product Type
Foods & Cosmetics
Office
Seattle District Office
People
  • Jean C. Colon Lopez (Company Rep)
  • Keegan B. Mixon (Issuing Officer)
View Company Profile

ID · 25172ea1-bb48-487a-aa82-927fb2618376

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1288684
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling, and Economics
Outcome
Form 483 issued

FDA Citations

12
  1. 21 CFR 111.260Batch record - required information
  2. 21 CFR 111.70(d)Specifications - labels, packaging
  3. 21 CFR 111.75(c)Specifications met - verify; finished batch
  4. 21 CFR 111.70(c)(1)In-process specification
  5. 21 CFR 111.320(a)Examination, testing; appropriate
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.75(e)Product - visually examine, identified
  8. 21 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition
  9. 21 CFR 111.303Written procedures - follow; laboratory
  10. 21 CFR 111.70(e)Specifications - finished dietary supplement

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of The Herbalist Inc

5
DateClassificationOfficeProject area
September 14, 2022VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
November 30, 2017VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
November 4, 2016OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 29, 2013NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 28, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for The Herbalist Inc
  • FDA Inspection 1179593 - 2022-09-14
  • FDA Inspection 1032482 - 2017-11-30
  • FDA Inspection 992726 - 2016-11-04
  • FDA Inspection 856825 - 2013-10-29
  • FDA Inspection 826572 - 2013-03-28

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