FDA Inspection
TransMedics, Inc.TransMedics, Inc. – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns TransMedics, Inc., with an inspection on August 12, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · cd6faf0c-7b12-4743-849f-1eadb2dcdc27
Inspection Facts
- Inspection number
- 1330760
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.2.1Requirements related to product not determined
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of TransMedics, Inc.
6| 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 |
| March 18, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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 918606 - 2015-03-18
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