FDA Inspection
Bioclinica, Inc.Bioclinica, Inc. – FDA Inspection, Mar 7, 2012
Record Details
This FDA Inspection record concerns Bioclinica, Inc., with an inspection on March 7, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bioclinica, Inc.
- Inspection Date
- March 7, 2012
- Product Type
- Drugs
View Company Profile
ID · fac79025-ea04-459c-9475-a622f96c91e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770535
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
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Other FDA inspections of Bioclinica, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2013 | NAI | Bioresearch Monitoring | |
| October 29, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 4, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 9, 2008 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Bioclinica, Inc.
- FDA Inspection 814426 - 2013-01-14
- FDA Inspection 695243 - 2010-10-29
- FDA Inspection 682696 - 2010-10-04
- FDA Inspection 550589 - 2008-12-09
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