Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-02-14.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2019 – 14 Feb 2019 | Medical Devices & Rad Health | 483 | On file |
| 10 Jun 2013 – 13 Jun 2013 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2013
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dawn M Braswell
13 Jun 2013
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Catherine J Laufmann, Dawn M Braswell
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 1010.2(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sharplight Technologies' 2 Form 483s
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