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 2647346.
Observations4
Issue DateMay 31, 2019
Status1 Related Warning Letter
Related Inspections5
Establishment Details
Firm
Medtronic Puerto Rico Operations Co.
Location
Humacao, Puerto Rico, United States
FEI Number
2647346
Product Type
Devices
Issue Date
May 31, 2019
Country
United States
Inspection History, 2010 to 2019
NAI1
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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