FDA Inspection
Brain Alert LLCBrain Alert LLC – FDA Inspection, Jul 12, 2017
Record Details
This FDA Inspection record concerns Brain Alert LLC, with an inspection on July 12, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · ac6541f5-60b4-4436-a291-1bfa674edee1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1017630
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.455(a)Hold - temperature, humidity, light
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.365(d)Chemical, microbiological, other test-contaminated components
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Other FDA inspections of Brain Alert LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2014 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 13, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Brain Alert LLC
- FDA Inspection 898585 - 2014-09-29
- FDA Inspection 832115 - 2013-05-13
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