FDA Inspection 735374 — Huestis Machine Corporation
The FDA completed an inspection of Huestis Machine Corporation on June 24, 2011 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 24, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bristol, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |