Company
United StatesSummit Medical Products, Inc., Sandy, UT – FDA Inspections
Inspection records and compliance data for Summit Medical Products, Inc. in Sandy, Utah. 3 FDA inspections on record, last inspected December 12, 2016.
Company Profile
This profile covers Summit Medical Products, Inc. based in Sandy, Utah, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 24, 2010. Last inspected December 12, 2016.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 12, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 994518 |
| May 10, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831196 |
| September 24, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 682386 |
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 Products, Inc.
FEI Number
1000117099
Address
504 W 8360 S Ste 212, Sandy, Utah 84070, United States
Country
United States
ID: 8d179876-5eb9-4c85-b96a-96b06e006eaa