Company
United StatesMidmark Corporation, Versailles, OH – FDA Inspections
Inspection records and compliance data for Midmark Corporation in Versailles, Ohio. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 15, 2019.
Company Profile
This profile covers Midmark Corporation based in Versailles, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 12, 2011. Last inspected August 15, 2019.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Acceptable supplier records, inadequate records2 inspections
- Design validation - user needs and intended uses1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2019 | Not classified | Medical Devices & Rad Health | 1134001 |
| April 2, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1048753 |
| December 9, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 998373 |
| June 9, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 880282 |
| June 28, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 790449 |
| September 12, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 742849 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Midmark Corporation
FEI Number
1523530
Address
60 Vista Dr, Versailles, Ohio 45380, United States
Country
United States
ID: 9ff66280-9748-473b-b233-44483b82a63b