FDA Inspection
Bighorn Botanicals IncBighorn Botanicals Inc – FDA Inspection, Sep 12, 2017
Record Details
This FDA Inspection record concerns Bighorn Botanicals Inc, with an inspection on September 12, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
View Company Profile
ID · eee6acf8-f775-4b1e-836b-854a85bef9ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024968
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.160(d)(2)Packaging, labels - unique identifier, disposition
- 21 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bighorn Botanicals Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 16, 2023 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| August 11, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 10, 2011 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Bighorn Botanicals Inc
- FDA Inspection 1248212 - 2024-08-30
- FDA Inspection 1220115 - 2023-06-16
- FDA Inspection 894426 - 2014-08-11
- FDA Inspection 754004 - 2011-11-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.