FDA Inspection
Bio-Signal Group Corp.Bio-Signal Group Corp. – FDA Inspection, Feb 19, 2020
Record Details
This FDA Inspection record concerns Bio-Signal Group Corp., with an inspection on February 19, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio-Signal Group Corp.
- Inspection Date
- February 19, 2020
- Product Type
- Devices
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ID · 9fe12e93-8ae7-4546-afc3-6497773a2cec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118219
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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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 |
| November 9, 2018 | 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 1071458 - 2018-11-09
- FDA Inspection 936931 - 2015-07-07
- FDA Inspection 769843 - 2012-02-27
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