FDA Inspection 1083772 — Henke Sass Wolf Of America,Inc
The FDA completed an inspection of Henke Sass Wolf Of America,Inc on March 25, 2019 in Dudley, 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
- March 25, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dudley, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |