Company
United StatesOmnitech Systems, Inc., Valparaiso, IN – FDA Inspections
Inspection records and compliance data for Omnitech Systems, Inc. in Valparaiso, Indiana. 2 FDA inspections on record, last inspected June 13, 2018.
Company Profile
This profile covers Omnitech Systems, Inc. based in Valparaiso, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2010. Last inspected June 13, 2018.
Most cited issue areas
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1060993 |
| February 3, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 643042 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Omnitech Systems, Inc.
FEI Number
1000518605
Address
450 Campbell St Ste 2, Valparaiso, Indiana 46385, United States
Country
United States
ID: 5fb5b872-bdb4-4d9c-b72c-f70840a5dad5