FDA Inspection
Isolux, LLCIsolux, LLC – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Isolux, LLC, with an inspection on January 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isolux, LLC
- Inspection Date
- January 22, 2010
- Product Type
- Devices
View Company Profile
ID · fda501d2-f18f-475f-a659-0e1496c16c80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639866
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)(3)Results
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Isolux, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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