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Konica Minolta Healthcare, Americas, Inc., Garner, NC – FDA Inspections

Inspection records and compliance data for Konica Minolta Healthcare, Americas, Inc. in Garner, North Carolina. 2 FDA inspections on record, 1 Form 483, last inspected August 25, 2017.

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Company Profile

This profile covers Konica Minolta Healthcare, Americas, Inc. based in Garner, North Carolina, United States.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
1
Form 483s
1
Warning letters
0

First inspected August 20, 2014. Last inspected August 25, 2017.

Most cited issue areas

  • Lack of or inadequate complaint procedures1 inspection
  • Lack of or inadequate final acceptance procedures1 inspection
  • Lack of or inadequate process validation1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
August 25, 2017VAIMedical Devices & Rad Health · Compliance: Devices1022872
August 20, 2014NAIMedical Devices & Rad Health · Compliance: Devices897362
FDA documents

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

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Company Information

Name

Konica Minolta Healthcare, Americas, Inc.

FEI Number

3002885429

Address

2217 Us Highway 70 E, Garner, North Carolina 27529, United States

Country

United States

ID: 29f0ab36-f07d-4389-a4b0-6b112712e14b

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