Company
United StatesBioclinica, Inc., Newtown, PA – FDA Inspections
Inspection records and compliance data for Bioclinica, Inc. in Newtown, Pennsylvania. 5 FDA inspections on record, last inspected January 14, 2013.
Company Profile
This profile covers Bioclinica, Inc. based in Newtown, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2008. Last inspected January 14, 2013.
Most cited issue areas
- General responsibilities of sponsors1 inspection
- QAU: authorize deviations from protocols or SOPs1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 14, 2013 | NAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 814426 |
| March 7, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 770535 |
| October 29, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 695243 |
| October 4, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 682696 |
| December 9, 2008 | NAI | Human Drugs · Bioresearch Monitoring | 550589 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bioclinica, Inc.
FEI Number
3008381429
Address
826 Newtown Yardley Rd, Newtown, Pennsylvania 18940, United States
Country
United States
ID: 977908d6-8067-4569-b578-2121f0152c09