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 1121308.
Observations8
Issue DateJuly 11, 2015
Status2 Related Warning Letters
Establishment TypeMedical Device Manufacturer
Related Inspections7
Establishment Details
Firm
Integra LifeSciences Corporation
Location
Plainsboro, New Jersey, United States
FEI Number
1121308
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
July 11, 2015
Country
United States
Inspection History, 2009 to 2024
NAI3
VAI1
OAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist