Medtronic Puerto Rico Operations Co.

Form 483

Humacao, Puerto Rico, United StatesFEI 2647346Issued March 31, 2017

View FDA's Record for This Firm

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.

Observations3

Issue DateMarch 31, 2017

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: March 31, 2017
Country: United States

Inspection History, 2010 to 2019

NAI1

VAI4

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

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Medtronic Puerto Rico Operations Co. FDA Form 483, Humacao, Puerto Rico, March 31, 2017