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 3006705815.
Observations6
Issue DateAugust 12, 2015
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections8
Establishment Details
Firm
Abbott Medical
Issued To
St. Jude Medical Puerto Rico LLC
Location
Arecibo, Maryland, United States
FEI Number
3006705815
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
August 12, 2015
Country
United States
Inspection History, 2010 to 2022
NAI3
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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