Ascensia Diabetes Care U.S. Inc.

Form 483

Mishawaka, Indiana, United StatesFEI 1826988Issued January 10, 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 1826988.

Observations1

Issue DateJanuary 10, 2017

StatusNo Warning Letter

Related Inspections4

Establishment Details

Firm: Ascensia Diabetes Care U.S. Inc.
Location: Mishawaka, Indiana, United States
FEI Number: 1826988
Product Type: Devices
Issue Date: January 10, 2017
Country: United States

Inspection History, 2010 to 2017

NAI3

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.

Ascensia Diabetes Care U.S. Inc. FDA Form 483, Mishawaka, Indiana, January 10, 2017