Company
United StatesIsolux, LLC, Chatsworth, CA – FDA Inspections
Inspection records and compliance data for Isolux, LLC in Chatsworth, California. 3 FDA inspections on record (1 OAI), last inspected September 14, 2016.
Company Profile
This profile covers Isolux, LLC based in Chatsworth, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected January 22, 2010. Last inspected September 14, 2016.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 984872 |
| November 6, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 948806 |
| January 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 639866 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Isolux, LLC
FEI Number
3002249830
Address
19749 Dearborn St, Chatsworth, California 91311, United States
Country
United States
ID: c651c7d4-26e1-4eef-8290-9a6256d61702