FDA Inspection 663430 — Innovative Medical Equipment
The FDA completed an inspection of Innovative Medical Equipment on May 18, 2010 in Beachwood, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 18, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |