FDA Inspection
Copper Creek Medical, Inc.Copper Creek Medical, Inc. – FDA Inspection, Nov 20, 2012
Record Details
This FDA Inspection record concerns Copper Creek Medical, Inc., with an inspection on November 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Copper Creek Medical, Inc.
- Inspection Date
- November 20, 2012
- Product Type
- Drugs
View Company Profile
ID · 7d505a94-8570-4d71-8752-c1903ed250fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808762
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Copper Creek Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 23, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Copper Creek Medical, Inc.
- FDA Inspection 730748 - 2011-04-06
- FDA Inspection 637237 - 2009-12-23
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