Company
United StatesBionx Medical Technologies, Inc., Bedford, MA – FDA Inspections
Inspection records and compliance data for Bionx Medical Technologies, Inc. in Bedford, Massachusetts. 2 FDA inspections on record, last inspected March 25, 2014.
Company Profile
This profile covers Bionx Medical Technologies, Inc. based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 13, 2011. Last inspected March 25, 2014.
Most cited issue areas
- Design verification - documentation1 inspection
- Documentation1 inspection
- Equipment Installation, Placement, Specified Requirements1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 25, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 871457 |
| October 13, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 749293 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bionx Medical Technologies, Inc.
FEI Number
3008869754
Address
4 Crosby Dr, Bedford, Massachusetts 01730, United States
Country
United States
ID: 6fdfb295-9c7f-4ae7-9eda-9e3b5c5b9592