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Sysmex Corporation, Kobe, Japan – FDA Inspections

Inspection records and compliance data for Sysmex Corporation in Kobe. 1 FDA inspection on record, last inspected January 17, 2013.

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Company Profile

This profile covers Sysmex Corporation based in Kobe, Japan.

FDA Inspection History

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

Inspected January 17, 2013.

Most cited issue areas

  • Lack of or inadequate procedures1 inspection
  • Report of risk to health1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 17, 2013VAIMedical Devices & Rad Health · Postmarket Assurance: Devices817094
FDA documents

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

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Company Information

Name

Sysmex Corporation

FEI Number

3002808301

Address

4 Chome 4-4, Nishi-Ku, Kobe, Japan

Country

Japan

ID: 89f38e7f-fd33-41d6-ac9e-af2cca847ae0

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