FDA Inspection
Atrium, Inc.Atrium, Inc. – FDA Inspection, Jul 17, 2014
Record Details
This FDA Inspection record concerns Atrium, Inc., with an inspection on July 17, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Atrium, Inc.
- Inspection Date
- July 17, 2014
- Product Type
- Food/cosmetics
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ID · c32134f3-d404-457b-93b8-82ea0324d302
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 887380
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 111.210(h)(1)Instructions; specifications; packaged, labeled
- 21 CFR 111.73Specifications met - component identity
- 21 CFR 111.75(h)Tests, examinations - scientifically valid
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.410(c)Packaging, labels - master manufacturing record
- 21 CFR 111.27(a)Equipment - design - suitable
- 21 CFR 111.123(a)(5)Quality control operations - reprocessing
- 21 CFR 111.77(b)Specifications not met - identity; component, reject
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Other FDA inspections of Atrium, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 24, 2012 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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