1178260
iRhythm Technologies, Inc. — FEI 3021769057
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 12, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cypress, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |