FDA Inspection
Aetherea, LLCAetherea, LLC – FDA Inspection, Aug 25, 2017
Record Details
This FDA Inspection record concerns Aetherea, LLC, with an inspection on August 25, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Jennifer Guttuso (Issuing Officer)
- Jon C. Polzine (Company Rep)
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ID · fff1aa23-3c2a-480c-a2c6-b93949c7dd7a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1023105
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 111.12(b)Personnel - quality control operations; responsibilities
- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.80(c)Specifications - representative samples; finished batch
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
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Other FDA inspections of Aetherea, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 11, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Aetherea, LLC
- FDA Inspection 1177524 - 2022-07-28
- FDA Inspection 1097895 - 2019-06-11
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