Company
CanadaO-Two Medical Technologies, Inc., Brampton, Canada – FDA Inspections
Inspection records and compliance data for O-Two Medical Technologies, Inc. in Brampton. 2 FDA inspections on record, last inspected August 04, 2011.
Company Profile
This profile covers O-Two Medical Technologies, Inc. based in Brampton, Canada.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 11, 2008. Last inspected August 4, 2011.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 4, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 737564 |
| December 11, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 553077 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
O-Two Medical Technologies, Inc.
FEI Number
3002807836
Address
45A Armthorpe Road, Brampton, Canada
Country
Canada
ID: 6188acdb-b2a6-4f09-9fb1-5d6c71353559