FDA Inspection 828941 — Huestis Machine Corporation
The FDA completed an inspection of Huestis Machine Corporation on May 13, 2013 in Bristol, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bristol, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 5715 | 21 CFR 1002.41(a)(1) | Forwarding, holding, preserving distribution data |