FDA Inspection
TransMedics, Inc.TransMedics, Inc. – FDA Inspection, Mar 18, 2015
Record Details
This FDA Inspection record concerns TransMedics, Inc., with an inspection on March 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TransMedics, Inc.
- Inspection Date
- March 18, 2015
- Product Type
- Devices
View Company Profile
ID · dd0f5d18-368d-48c0-af36-658bcadb2acc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918606
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TransMedics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 14, 2019 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| April 26, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 19, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TransMedics, Inc.
- FDA Inspection 1129937 - 2020-09-18
- FDA Inspection 1082561 - 2019-03-14
- FDA Inspection 1013092 - 2017-04-26
- FDA Inspection 1010589 - 2017-04-19
- FDA Inspection 914141 - 2015-02-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.