FDA Inspection 1231104 — ORAL IQ LLC
The FDA completed an inspection of ORAL IQ LLC on Feb 23, 2024 in West Hollywood, CA. 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
- Feb 23, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Hollywood, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |