FDA Inspection 1112957 — Gentell
The FDA completed an inspection of Gentell on Dec 16, 2019 in Bristol, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bristol, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |