1103309
Apollo Renal Therapeutics, LLC — FEI 3010032115
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ocala, FL (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 |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |