FDA Inspection 888858 — Hi Tech Mold & Tool, Inc.
The FDA completed an inspection of Hi Tech Mold & Tool, Inc. on July 30, 2014 in Pittsfield, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pittsfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |