Company
United StatesSummit Medical, LLC, Eagan, MN – FDA Inspections
Inspection records and compliance data for Summit Medical, LLC in Eagan, Minnesota. 8 FDA inspections on record (1 OAI), 3 Form 483s, last inspected May 14, 2018.
Company Profile
This profile covers Summit Medical, LLC based in Eagan, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 2
- NAI
- 5
- Form 483s
- 3
- Warning letters
- 0
First inspected November 6, 2009. Last inspected May 14, 2018.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate receiving acceptance procedures2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1051976 |
| March 9, 2018 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1045106 |
| November 10, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 992583 |
| March 4, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 916770 |
| May 5, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 878518 |
| January 28, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 816910 |
| September 7, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 801860 |
| November 6, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 629496 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Summit Medical, LLC
FEI Number
3008719017
Address
815 Vikings Pkwy Ste 100, Eagan, Minnesota 55121, United States
Country
United States
ID: 0f35412d-244a-4540-aeef-1cb3ffc18483