Company
United StatesOndaMed Inc, Washingtonville, NY – FDA Inspections
Inspection records and compliance data for OndaMed Inc in Washingtonville, New York. 3 FDA inspections on record, 1 Form 483, last inspected September 28, 2018.
Company Profile
This profile covers OndaMed Inc based in Washingtonville, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 17, 2015. Last inspected September 28, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 28, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1067339 |
| August 15, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 986755 |
| August 17, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 938468 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OndaMed Inc
FEI Number
3011088301
Address
5 Fairlawn Dr Ste 200, Washingtonville, New York 10992, United States
Country
United States
ID: fe0ea238-d61c-4acd-b986-5a9da81bd84c