Abiomed, Inc.

Form 483FOIA Uncovered

Danvers, Massachusetts, United StatesFEI 1220648Issued April 13, 2023

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 1220648.

Observations6

Issue DateApril 13, 2023

Status1 Related Warning Letter

Related Inspections9

Establishment Details

Firm: Abiomed, Inc.
Location: Danvers, Massachusetts, United States
FEI Number: 1220648
Product Type: Devices
Issue Date: April 13, 2023
Country: United States

Inspection History, 2010 to 2025

NAI5

VAI2

OAI2

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

Act on This Form 483

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Abiomed, Inc. FDA Form 483, Danvers, Massachusetts, April 13, 2023