FDA Inspection 1065455 — Arc Devices USA Inc
The FDA completed an inspection of Arc Devices USA Inc on Aug 31, 2018 in West Palm Beach, FL. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 31, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Palm Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |