FDA Inspection
TransMedics, Inc.TransMedics, Inc. – FDA Inspection, Apr 19, 2017
Record Details
This FDA Inspection record concerns TransMedics, Inc., with an inspection on April 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Abby E. Pelletier (Issuing Officer)
View Company Profile
ID · 550d9fe9-b202-49f5-aa2d-ffb987e269d5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1010589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
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 |
| March 18, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 918606 - 2015-03-18
- 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.