Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2431293.
Observations5
Issue DateAugust 22, 2018
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections4
Establishment Details
Firm
FUJIFILM Healthcare Americas Corporation
Issued To
Fujifilm Medical Systems U.S.A., Inc.
Location
Wayne, New Jersey, United States
FEI Number
2431293
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
August 22, 2018
Country
United States
Inspection History, 2010 to 2019
VAI3
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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