Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-03-20.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2017 – 20 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2016 – 24 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jun 2016 – 21 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 16 Nov 2011 | Not recorded | 483 | View 483 → |
| 17 Nov 2005 | Not recorded | Clean | |
| 20 May 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Linda Linh N Adams, Linda Linh T Nguyen
20 Mar 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Linda Linh N Adams, Linda Linh T Nguyen
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New Star Lasers, Inc.'s 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat