FDA Inspection
TransMedics, Inc.TransMedics, Inc. – FDA Inspection, Mar 14, 2019
Record Details
This FDA Inspection record concerns TransMedics, Inc., with an inspection on March 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ab75095b-fd15-4bfa-9a00-6d871ed0625b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082561
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.150(b)(2)Sponsor notification of IRB approval withdrawal
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 |
| 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 |
| 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 1013092 - 2017-04-26
- FDA Inspection 1010589 - 2017-04-19
- FDA Inspection 918606 - 2015-03-18
- FDA Inspection 914141 - 2015-02-04
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