Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-08-07.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2014 – 7 Aug 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jun 2011 | Not recorded | 483 | View 483 → |
| 22 Nov 2010 | Not recorded | 483 | View 483 → |
| 22 Mar 2007 | Not recorded | Clean | |
| 21 Mar 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Aug 2014
21 CFR 820.70(g)(2)
Periodic equipment inspection lack of or inadequate procedu
Cited by Lindsay R Hatch
14 Jun 2011
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Lindsay R Hatch
14 Jun 2011
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Lindsay R Hatch
14 Jun 2011
21 CFR 820.40(b)
Document changes, review and approval, communication
Cited by Lindsay R Hatch
Investigators
FDA investigators tied to this site in the record.
Lindsay R Hatch3 insp.
Barbara T Carmichael1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sunoptic Technologies, LLC'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