TransMedics, Inc.

Form 483

Andover, Massachusetts, United StatesFEI 3003152463Issued March 18, 2015

View FDA's Record for This Firm

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 18, 2015

StatusNo Warning Letter

Related Inspections6

Establishment Details

Firm: TransMedics, Inc.
Location: Andover, Massachusetts, United States
FEI Number: 3003152463
Product Type: Devices
Issue Date: March 18, 2015
Country: United States

Inspection History, 2015 to 2020

NAI2

VAI4

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

TransMedics, Inc. FDA Form 483, Andover, Massachusetts, March 18, 2015