FDA Inspection
Earthborn Products IncEarthborn Products Inc – FDA Inspection, Mar 20, 2019
Record Details
This FDA Inspection record concerns Earthborn Products Inc, with an inspection on March 20, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 0c28e7f2-e6ee-47d7-89c5-ae82b45f0111
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083266
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.180(b)(3)Documentation - components
- 21 CFR 111.375(b)Records - manufacturing operations; written procedures
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.23(c)Records - water
- 21 CFR 111.35(b)(1)Written procedures - equipment, utensils; make, keep
- 21 CFR 111.180(b)(1)Written procedures - product received
- 21 CFR 111.325(a)Written procedures, laboratory operations
- 21 CFR 111.205(a)Master manufacturing record - each batch
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Other FDA inspections of Earthborn Products Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 25, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Earthborn Products Inc
- FDA Inspection 1215192 - 2023-08-01
- FDA Inspection 799774 - 2012-09-25
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