Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-16.
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 |
|---|---|---|---|
| 13 Nov 2023 – 16 Nov 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Aug 2017 – 17 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 26 Sep 2016 – 29 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 13 May 2013 – 16 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2013
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
John A Sciacchitano1 insp.
Adam S Freeman1 insp.
Nancy L Neiger1 insp.
Frank J Marciniak1 insp.
Thomas E Friel1 insp.
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 | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DOT Gmbh'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