FDA Inspection 1091039 — MODULATED IMAGING, INC.
The FDA completed an inspection of MODULATED IMAGING, INC. on May 24, 2019 in Costa Mesa, 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
- May 24, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |