Company
United StatesTransMedics, Inc., Andover, MA – FDA Inspections
Inspection records and compliance data for TransMedics, Inc. in Andover, Massachusetts. 6 FDA inspections on record, 3 Form 483s, last inspected September 18, 2020.
Company Profile
This profile covers TransMedics, Inc. based in Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected February 4, 2015. Last inspected September 18, 2020.
Most cited issue areas
- Documentation1 inspection
- Sponsor notification of IRB approval withdrawal1 inspection
- Sponsor records of investigator agreements inadequate1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1129937 |
| March 14, 2019 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1082561 |
| April 26, 2017 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1013092 |
| April 19, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1010589 |
| March 18, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 918606 |
| February 4, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 914141 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
TransMedics, Inc.
FEI Number
3003152463
Address
200 Minuteman Rd Ste 302, Andover, Massachusetts 01810, United States
Country
United States
ID: 47d83874-82e5-40b4-a72c-8bb17429044d