FDA Inspection 1059095 — OriGen Biomedical, Inc.
The FDA completed an inspection of OriGen Biomedical, Inc. on Jul 5, 2018 in Austin, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 5, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |