FDA Inspection
New Star Lasers, Inc.New Star Lasers, Inc. – FDA Inspection, Aug 24, 2016
Record Details
This FDA Inspection record concerns New Star Lasers, Inc., with an inspection on August 24, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- New Star Lasers, Inc.
- Inspection Date
- August 24, 2016
- Product Type
- Devices
View Company Profile
ID · a14b7c46-1ac7-44f8-b96d-24d8748159e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988545
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New Star Lasers, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for New Star Lasers, Inc.
- FDA Inspection 1027420 - 2017-03-20
- FDA Inspection 981838 - 2016-06-21
- FDA Inspection 754436 - 2011-11-16
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