FDA Inspection
Coats Aloe International, Inc.Coats Aloe International, Inc. – FDA Inspection, Mar 4, 2014
Record Details
This FDA Inspection record concerns Coats Aloe International, Inc., with an inspection on March 4, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- March 4, 2014
- Product Type
- Food/cosmetics
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ID · ebe95516-ffc0-4567-89de-242350e5e6b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866493
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
7- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.27(a)Equipment - design - suitable
- 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
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Other FDA inspections of Coats Aloe International, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2011 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| January 15, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2009 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Coats Aloe International, Inc.
- FDA Inspection 733811 - 2011-07-08
- FDA Inspection 646088 - 2010-01-15
- FDA Inspection 613995 - 2009-09-18
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