FDA Inspection 987991 — Illuminoss Medical Inc.
The FDA completed an inspection of Illuminoss Medical Inc. on August 31, 2016 in East Providence, RI. 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
- August 31, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- East Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |