FDA Inspection
Copper Creek Medical, Inc.Copper Creek Medical, Inc. – FDA Inspection, Apr 6, 2011
Record Details
This FDA Inspection record concerns Copper Creek Medical, Inc., with an inspection on April 6, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Copper Creek Medical, Inc.
- Inspection Date
- April 6, 2011
- Product Type
- Drugs
View Company Profile
ID · c77e9a46-1254-4b3b-bd4f-2080207b0687
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730748
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 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 |
|---|---|---|---|
| November 20, 2012 | 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 808762 - 2012-11-20
- FDA Inspection 637237 - 2009-12-23
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