Company
United StatesMonteris Medical Corp, Minnetonka, MN – FDA Inspections
Inspection records and compliance data for Monteris Medical Corp in Minnetonka, Minnesota. 3 FDA inspections on record, 1 Form 483, last inspected October 04, 2018.
Company Profile
This profile covers Monteris Medical Corp based in Minnetonka, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2014. Last inspected October 4, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - documentation1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 4, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1067866 |
| June 30, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 983042 |
| November 14, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 910131 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Monteris Medical Corp
FEI Number
3009970070
Address
131 Cheshire Ln Ste 100, Minnetonka, Minnesota 55305, United States
Country
United States
ID: e1fb466f-c3cd-480b-802f-105d71d1dbd1