Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-30.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2022 – 30 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2020 – 19 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Nov 2018 – 9 Nov 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jul 2015 – 7 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Feb 2012 | Not recorded | 483 | View 483 → |
| 12 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Stephen C Smith3 insp.
James P Finn1 insp.
Crystal Nevins1 insp.
James W Whitney1 insp.
David J Feria1 insp.
John A Sciacchitano1 insp.
Darin S Wiegers1 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 | 4x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio-Signal Group Corp.'s 5 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