Company
United StatesOsteotech, Inc., Eatontown, NJ – FDA Inspections
Inspection records and compliance data for Osteotech, Inc. in Eatontown, New Jersey. 9 FDA inspections on record, 1 Form 483, last inspected June 18, 2024.
Company Profile
This profile covers Osteotech, Inc. based in Eatontown, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 1
- NAI
- 8
- Form 483s
- 1
- Warning letters
- 0
First inspected December 9, 2010. Last inspected June 18, 2024.
Most cited issue areas
- Aseptic processing---cleaning, disinfecting1 inspection
- Causing contamination, increasing risks1 inspection
- Controlling the labeling of HCT/Ps1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 18, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1245789 |
| August 12, 2021 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1150237 |
| July 30, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1060874 |
| August 10, 2017 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 1021037 |
| May 6, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 925160 |
| August 16, 2013 | NAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 845708 |
| August 16, 2013 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 845698 |
| May 3, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 780434 |
| December 9, 2010 | VAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 699572 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Osteotech, Inc.
FEI Number
3002600221
Address
201 Industrial Way W, Eatontown, New Jersey 07724, United States
Country
United States
ID: 916ecda8-a52b-4078-aadc-eaee17461f83