FDA Inspection 1017346 — Cleveland Medical Devices Inc
The FDA completed an inspection of Cleveland Medical Devices Inc on July 7, 2017 in Cleveland, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cleveland, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7322 | 21 CFR 56.111 (a)(2) | Risks to subjects reasonable |
| 7323 | 21 CFR 56.111(a)(3) | Selection of subjects equitable |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7370 | 21 CFR 56.111(c) | Children as subjects |