Company
United StatesOcusun, LLC, Novato, CA – FDA Inspections
Inspection records and compliance data for Ocusun, LLC in Novato, California. 3 FDA inspections on record, last inspected December 15, 2015.
Company Profile
This profile covers Ocusun, LLC based in Novato, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 29, 2009. Last inspected December 15, 2015.
Most cited issue areas
- Quality audits - Lack of or inadequate procedures2 inspections
- Control/distribution procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967464 |
| July 6, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 605251 |
| January 29, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 556138 |
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
Ocusun, LLC
FEI Number
3007289540
Address
150 Alameda Del Prado, Novato, California 94949, United States
Country
United States
ID: fe3a630d-9be7-4895-a796-0cdce62a479b