Company
United StatesVolk Optical Inc, Mentor, OH – FDA Inspections
Inspection records and compliance data for Volk Optical Inc in Mentor, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected September 28, 2017.
Company Profile
This profile covers Volk Optical Inc based in Mentor, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 26, 2009. Last inspected September 28, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 28, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1027501 |
| November 6, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 903132 |
| October 24, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 809759 |
| June 26, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 589876 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Volk Optical Inc
FEI Number
1000122772
Address
7893 Enterprise Dr, Mentor, Ohio 44060, United States
Country
United States
ID: fa891e36-e3d5-409b-a5e2-ad166c62956d