Company
United StatesMainstay Medical Limited US, Inc., Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Mainstay Medical Limited US, Inc. in Minneapolis, Minnesota. 2 FDA inspections on record, last inspected June 30, 2023.
Company Profile
This profile covers Mainstay Medical Limited US, Inc. based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 20, 2019. Last inspected June 30, 2023.
Most cited issue areas
- Sponsor progress reports for significant risk study1 inspection
- Sponsors" general responsibilities1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 30, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1216990 |
| December 20, 2019 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1113373 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
Mainstay Medical Limited US, Inc.
FEI Number
3013017877
Address
6601 Shingle Creek Pkwy Ste 200, Minneapolis, Minnesota 55430, United States
Country
United States
ID: 388b4bdd-fc55-41fd-b7d6-be304c73b5ae