Company
United StatesOsteotech, Inc., Shrewsbury, NJ – FDA Inspections
Inspection records and compliance data for Osteotech, Inc. in Shrewsbury, New Jersey. 2 FDA inspections on record, last inspected August 16, 2013.
Company Profile
This profile covers Osteotech, Inc. based in Shrewsbury, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2010. Last inspected August 16, 2013.
Most cited issue areas
- Acceptance criteria designed to prevent CD1 inspection
- Design adequate to bar spread of CD"s1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 845705 |
| December 9, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 699568 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Osteotech, Inc.
FEI Number
3002277646
Address
1151 Shrewsbury Ave, Shrewsbury, New Jersey 07702, United States
Country
United States
ID: f18faa68-ec2a-48d2-b71b-2a8a06d292bf