FDA Inspection
Claris Lifesciences IncClaris Lifesciences Inc – FDA Inspection, Feb 2, 2010
Record Details
This FDA Inspection record concerns Claris Lifesciences Inc, with an inspection on February 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Claris Lifesciences Inc
- Inspection Date
- February 2, 2010
- Product Type
- Drugs
View Company Profile
ID · fead83dc-fb9d-4e15-aaa2-96a9f95fb1c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642855
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.80(f)(1)Incomplete patient information on ICSR
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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Other FDA inspections of Claris Lifesciences Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 7, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Claris Lifesciences Inc
- FDA Inspection 782687 - 2012-05-18
- FDA Inspection 665008 - 2010-06-07
- FDA Inspection 594179 - 2009-07-13
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