Company
United StatesAmedica Biotech, Inc., Hayward, CA – FDA Inspections
Inspection records and compliance data for Amedica Biotech, Inc. in Hayward, California. 2 FDA inspections on record, last inspected January 18, 2013.
Company Profile
This profile covers Amedica Biotech, Inc. based in Hayward, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 24, 2011. Last inspected January 18, 2013.
Most cited issue areas
- Design control - no procedures1 inspection
- DMR - not or inadequately maintained1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 814172 |
| March 24, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 711879 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Amedica Biotech, Inc.
FEI Number
3003897257
Address
28301 Industrial Blvd Ste K, Hayward, California 94545, United States
Country
United States
ID: c3dcad29-2cda-42f7-a4bb-0317bd75a556