Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-13.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2024 – 13 May 2024 | Medical Devices & Rad Health | Clean | |
| 22 Nov 2022 – 23 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Sep 2021 – 16 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Oct 2019 – 15 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Nov 2022
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Stanley B Eugene
23 Nov 2022
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Stanley B Eugene
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 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 4x |
| 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 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Biedermann Motech, Inc.'s 3 Form 483s
Source PDFs 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