FDA Inspection
Bio-Botanica, Inc.Bio-Botanica, Inc. – FDA Inspection, May 5, 2025
Record Details
This FDA Inspection record concerns Bio-Botanica, Inc., with an inspection on May 5, 2025, issued by the New York District Office, covering foods & cosmetics.
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ID · 83dc768d-de48-4f39-9334-fc793f6de77b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268786
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications, quality; packaging, labeling
- 21 CFR 111.123(b)(2)Quality control - batch, product specifications
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Other FDA inspections of Bio-Botanica, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 27, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 9, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 15, 2016 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 8, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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