FDA Inspection 1173339 — Huestis Machine Corporation
The FDA completed an inspection of Huestis Machine Corporation on June 30, 2022 in Bristol, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- 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 |