Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003152463.
Observations1
Issue DateMarch 14, 2019
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
TransMedics, Inc.
Location
Andover, Massachusetts, United States
FEI Number
3003152463
Product Type
Devices
Issue Date
March 14, 2019
Country
United States
Inspection History, 2015 to 2020
NAI2
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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