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 2017865.
Observations13
Issue DateJuly 10, 2015
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections10
Establishment Details
Firm
Abbott Medical
Issued To
St. Jude Medical IESD
Location
Sylmar, California, United States
FEI Number
2017865
Establishment Type
Manufacturer
Product Type
Drugs
Issue Date
July 10, 2015
Country
United States
Inspection History, 2012 to 2023
NAI5
VAI3
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.