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Sunrise Medical US, LLC, Indianapolis, IN – FDA Inspections

Inspection records and compliance data for Sunrise Medical US, LLC in Indianapolis, Indiana. 2 FDA inspections on record, last inspected June 13, 2013.

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Company Profile

This profile covers Sunrise Medical US, LLC based in Indianapolis, Indiana, United States.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
2
NAI
0
Form 483s
0
Warning letters
0

First inspected February 9, 2009. Last inspected June 13, 2013.

Most cited issue areas

  • Complete files maintained1 inspection
  • Individual Report of Malfunction1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
June 13, 2013VAIMedical Devices & Rad Health · Compliance: Devices836094
February 9, 2009VAIMedical Devices & Rad Health · Compliance: Devices566043
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Key Electronics, Inc.
Jack Farr, II, M.D.
Nico Corp.
Company Information

Name

Sunrise Medical US, LLC

FEI Number

3006459587

Address

8401 Bearing Dr, Indianapolis, Indiana 46268, United States

Country

United States

ID: 5cffe518-e4ee-438e-ba71-d62b9195b7d7

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