FDA Inspection
Claris Lifesciences IncClaris Lifesciences Inc – FDA Inspection, Jul 13, 2009
Record Details
This FDA Inspection record concerns Claris Lifesciences Inc, with an inspection on July 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Claris Lifesciences Inc
- Inspection Date
- July 13, 2009
- Product Type
- Drugs
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ID · 2fed583f-796a-4c36-945b-848b3ae58480
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594179
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
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 |
| February 2, 2010 | 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 642855 - 2010-02-02
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