Nexgen Medical Systems, Inc.

Form 483

Wayzata, Minnesota, United StatesFEI 3008106780Issued July 18, 2011

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 3008106780.

Observations3

Issue DateJuly 18, 2011

StatusNo Warning Letter

Related Inspections2

Establishment Details

Firm: Nexgen Medical Systems, Inc.
Location: Wayzata, Minnesota, United States
FEI Number: 3008106780
Product Type: Devices
Issue Date: July 18, 2011
Country: United States

Inspection History, 2011 to 2018

NAI1

VAI1

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

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Nexgen Medical Systems, Inc. FDA Form 483, Wayzata, Minnesota, July 18, 2011