FDA Inspection 1239286 — Medstar Cardiovascular Research Network
The FDA completed an inspection of Medstar Cardiovascular Research Network on May 22, 2024 in Washington, DC. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |