Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-28.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2022 – 28 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Apr 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Oct 2022
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Francis Pham
28 Oct 2022
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Gregory M Bessette, Francis Pham
19 Apr 2018
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Michael P Sweeney
19 Apr 2018
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Gregory M Bessette, Michael P Sweeney
19 Apr 2018
21 CFR 1030.10(c)(3)(iii)
Measurements with tap water container
Cited by Gregory M Bessette, Michael P Sweeney
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 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1030.10(c)(3)(iii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Miele & Cie. KG's 3 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