Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-30.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Sep 2021 – 30 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Aug 2013 – 10 Sep 2013 | Medical Devices & Rad Health | 483 | On file |
| 29 Apr 2011 | Not recorded | 483 | View 483 → |
| 16 Mar 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Sep 2021
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Sara M Onyango, David C Sullivan
30 Sep 2021
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Sara M Onyango, David C Sullivan
30 Sep 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Sara M Onyango, David C Sullivan
30 Sep 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Sara M Onyango, David C Sullivan
30 Sep 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Sara M Onyango, David C Sullivan
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 | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SDI Diagnostics, 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