Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-06.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2026 – 6 Apr 2026 | Medical Devices & Rad Health | Clean | |
| 18 Sep 2023 – 19 Sep 2023 | Medical Devices & Rad Health | Clean | |
| 25 Jun 2018 – 29 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 14 Apr 2015 – 15 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 27 May 2014 – 3 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Apr 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2014
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Frank J Marciniak
3 Jun 2014
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Amy M Cramer2 insp.
Meredith L Sheridan2 insp.
Shirley S Wen1 insp.
William R Chang1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nano-Ditech Corporation's 2 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