FDA Inspection 1147392 — Deborah Heart & Lung Center IRB
The FDA completed an inspection of Deborah Heart & Lung Center IRB on July 26, 2021 in Browns Mills, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Browns Mills, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7279 | 21 CFR 56.107(f) | Invited individual allowed to vote with IRB |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |