1173339
Huestis Machine Corporation — FEI 1219183
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bristol, RI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |