FDA Inspection 1071458 — Bio-Signal Group Corp.
The FDA completed an inspection of Bio-Signal Group Corp. on November 9, 2018 in Acton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Acton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3115 | 21 CFR 820.70(h) | Use and removal, Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |