FDA Inspection 1231989 — APEX DENTAL SLEEP LAB LLC
The FDA completed an inspection of APEX DENTAL SLEEP LAB LLC on February 22, 2024 in La Mesa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- La Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22796 | 21 CFR 801.40(a) | Form of a unique device identifier |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |