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Fukuda Denshi Co, Ltd, Bunkyo, Japan – FDA Inspections

Inspection records and compliance data for Fukuda Denshi Co, Ltd in Bunkyo. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected November 04, 2011.

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Company Profile

This profile covers Fukuda Denshi Co, Ltd based in Bunkyo, Japan.

FDA Inspection History

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

Inspected November 4, 2011.

Most cited issue areas

  • Design validation - documentation1 inspection
  • Design verification - documentation1 inspection
  • Info evaluated to determine if event was reportable1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
November 4, 2011OAIMedical Devices & Rad Health · Compliance: Devices755756
FDA documents

Warning Letters (1)

  • Warning Letters · November 4, 2011
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Company Information

Name

Fukuda Denshi Co, Ltd

FEI Number

1000110325

Address

39 Hongo, Hongo; Chome, Bunkyo, Japan

Country

Japan

ID: dbcc33b1-f95f-4272-8084-69fb0bd9d540

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