FDA Inspection
Brand New Energy, LLCBrand New Energy, LLC – FDA Inspection, May 24, 2017
Record Details
This FDA Inspection record concerns Brand New Energy, LLC, with an inspection on May 24, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Christopher D. Washington (Issuing Officer)
- Rocio Guzman-Velazquez
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ID · c0f5835d-3953-443e-8659-65bd814ae143
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012077
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.460(a)Hold, identify - in-process material
- 21 CFR 111.15(b)(1)Physical plant - clean and sanitary
- 21 CFR 111.23(b)Records - cleaning, pest control
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.15(a)(1)Grounds - equipment, litter, weeds
- 21 CFR 111.20(c)(3)Physical plant - separate areas for products
- 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
Showing 10 of 11 citations.
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Other FDA inspections of Brand New Energy, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 28, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 30, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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