FDA Inspection
TransMedics, Inc.TransMedics, Inc. – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns TransMedics, Inc., with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b1d17759-adae-4e8e-ba92-be7863d6d17b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013092
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
- 21 CFR 812.25(e)Sponsor's lack of written monitoring procedures
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 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 1082561 - 2019-03-14
- FDA Inspection 1010589 - 2017-04-19
- FDA Inspection 918606 - 2015-03-18
- FDA Inspection 914141 - 2015-02-04
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