Company
United StatesBZ Medical, Inc., Portland, OR – FDA Inspections
Inspection records and compliance data for BZ Medical, Inc. in Portland, Oregon. 2 FDA inspections on record, 1 Form 483, last inspected August 15, 2017.
Company Profile
This profile covers BZ Medical, Inc. based in Portland, Oregon, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 27, 2013. Last inspected August 15, 2017.
Most cited issue areas
- Lack of or inadequate DHR procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1021665 |
| December 27, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 859918 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BZ Medical, Inc.
FEI Number
3009182435
Address
6611 Sw Burlingame Ave, Portland, Oregon 97239, United States
Country
United States
ID: cec93628-3aec-47c2-a26d-3b0948d792ec