Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-06.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jun 2019 | Medical Devices & Rad Health | 483 | On file |
| 8 May 2017 – 9 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Apr 2014 – 23 Apr 2014 | Medical Devices & Rad Health | 483 | On file |
| 8 Jun 2011 | Not recorded | 483 | On file |
| 14 May 2010 | Not recorded | 483 | View 483 → |
| 19 Mar 2009 | Not recorded | 483 | On file |
| 23 Mar 2004 | Not recorded | Clean | |
| 25 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2017
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Michael P Sweeney
9 May 2017
21 CFR 1030.10(c)(2)(vi)
Means to monitor interlocks
Cited by Gregory M Bessette, Michael P Sweeney
23 Jun 2015
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Michael P Sweeney, Joseph C Teixeira, Mark K Tseng
14 May 2010
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Andre S Lamontagne
Investigators
FDA investigators tied to this site in the record.
Gregory M Bessette2 insp.
Michael P Sweeney2 insp.
Joseph C Teixeira2 insp.
Emir Galevi2 insp.
Andre S Lamontagne2 insp.
Francis Pham1 insp.
Mark K Tseng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1030.10(c)(2)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dongbu Daewoo Microwave Oven (Tianjin) Co., Ltd.'s 7 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