Company
United StatesSteriGear, LLC, Pleasant Grove, UT – FDA Inspections
Inspection records and compliance data for SteriGear, LLC in Pleasant Grove, Utah. 4 FDA inspections on record, 1 Form 483, last inspected March 22, 2023.
Company Profile
This profile covers SteriGear, LLC based in Pleasant Grove, Utah, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2011. Last inspected March 22, 2023.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - output does not meet input requirement1 inspection
- Documented evaluation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1200541 |
| March 6, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1004659 |
| May 9, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 878262 |
| March 17, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 714471 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SteriGear, LLC
FEI Number
3007608536
Address
30 S Main St, Pleasant Grove, Utah 84062, United States
Country
United States
ID: 6fc23f03-ccbf-4165-837b-b72883012630