FDA Inspection 1082561 — TransMedics, Inc.
The FDA completed an inspection of TransMedics, Inc. on March 14, 2019 in Andover, MA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Andover, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3043 | 21 CFR 812.150(b)(2) | Sponsor notification of IRB approval withdrawal |