FDA Inspection
Cosmedx Science Inc.Cosmedx Science Inc. – FDA Inspection, Apr 5, 2011
Record Details
This FDA Inspection record concerns Cosmedx Science Inc., with an inspection on April 5, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cosmedx Science Inc.
- Inspection Date
- April 5, 2011
- Product Type
- Drugs
View Company Profile
ID · b37076e8-1ccf-44c6-a2c9-8ffcfa31bedc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712022
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cosmedx Science Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosmedx Science Inc.
- FDA Inspection 941229 - 2015-08-26
- FDA Inspection 819176 - 2013-02-04
- FDA Inspection 771619 - 2012-03-13
- FDA Inspection 552271 - 2008-12-16
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