FDA Inspection 1016667 — Lightmed USA Inc
The FDA completed an inspection of Lightmed USA Inc on June 27, 2017 in San Clemente, CA. 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
- June 27, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Clemente, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |