Company
United StatesPiezosurgery Inc, Hilliard, OH – FDA Inspections
Inspection records and compliance data for Piezosurgery Inc in Hilliard, Ohio. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 28, 2017.
Company Profile
This profile covers Piezosurgery Inc based in Hilliard, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 12, 2010. Last inspected June 28, 2017.
Most cited issue areas
- Investigation of device failures2 inspections
- Lack of System for Event Evaluations2 inspections
- Servicing - Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1017087 |
| December 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 860088 |
| December 13, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 759923 |
| March 1, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 712899 |
| April 12, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 656861 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Piezosurgery Inc
FEI Number
3005282635
Address
4115 Leap Rd, Hilliard, Ohio 43026, United States
Country
United States
ID: 25c9540e-3b72-4b70-ab53-6a361d45bd6b