FDA Inspection
New Star Lasers, Inc.New Star Lasers, Inc. – FDA Inspection, Mar 20, 2017
Record Details
This FDA Inspection record concerns New Star Lasers, Inc., with an inspection on March 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · b6db37ed-4252-407c-9dd3-abf305764426
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027420
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New Star Lasers, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 988545 - 2016-08-24
- FDA Inspection 981838 - 2016-06-21
- FDA Inspection 754436 - 2011-11-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.