FDA Inspection 1059092 — Innovative Medical Equipment
The FDA completed an inspection of Innovative Medical Equipment on Jul 17, 2018 in Beachwood, OH. 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
- Jul 17, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |