1215340
Zyno Medical LLC — FEI 3006575795
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 16, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |