FDA Inspection 1130883 — Summa Health System IRB
The FDA completed an inspection of Summa Health System IRB on October 7, 2020 in Akron, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 7, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Akron, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |