Company
United StatesSunrise Medical (US) LLC, Fresno, CA – FDA Inspections
Inspection records and compliance data for Sunrise Medical (US) LLC in Fresno, California. 7 FDA inspections on record, 1 Form 483, last inspected June 15, 2017.
Company Profile
This profile covers Sunrise Medical (US) LLC based in Fresno, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected October 30, 2008. Last inspected June 15, 2017.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Report of Death or Serious Injury2 inspections
- Report of risk to health2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 15, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1014294 |
| May 6, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 976332 |
| April 15, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 922468 |
| October 24, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 901289 |
| January 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 763293 |
| May 17, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 661235 |
| October 30, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 544255 |
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
Sunrise Medical (US) LLC
FEI Number
2937137
Address
2842 N Business Park Ave, Fresno, California 93727, United States
Country
United States
ID: 07d00fa6-932c-49b4-a58b-521585ce3a87