FDA Inspection 1195256 — Genesis Biosystems, Inc
The FDA completed an inspection of Genesis Biosystems, Inc on January 9, 2023 in Lewisville, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 9, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lewisville, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |