FDA Inspection
Professional Botanicals, Inc.Professional Botanicals, Inc. – FDA Inspection, May 27, 2025
Record Details
This FDA Inspection record concerns Professional Botanicals, Inc., with an inspection on May 27, 2025, issued by the Denver District Office, covering foods & cosmetics.
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ID · bda26bce-4670-4d8e-9f05-1eacf54fb1c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270895
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
- 21 CFR 111.120(e)Quality control operations - quarantine
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
Showing 10 of 12 citations.
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Other FDA inspections of Professional Botanicals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 11, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 30, 2013 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 27, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Professional Botanicals, Inc.
- FDA Inspection 1038275 - 2018-01-22
- FDA Inspection 988266 - 2016-10-11
- FDA Inspection 857856 - 2013-10-30
- FDA Inspection 821443 - 2013-02-27
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