FDA Inspection
Bio-Signal Group Corp.Bio-Signal Group Corp. – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Bio-Signal Group Corp., with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e118efd1-2824-4c76-8e82-be92e5740e97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071458
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bio-Signal Group Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio-Signal Group Corp.
- FDA Inspection 1178459 - 2022-08-30
- FDA Inspection 1118219 - 2020-02-19
- FDA Inspection 936931 - 2015-07-07
- FDA Inspection 769843 - 2012-02-27
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.