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Osachi Co Ltd, Okaya, Japan – FDA Inspections

Inspection records and compliance data for Osachi Co Ltd in Okaya. 2 FDA inspections on record (1 OAI), last inspected September 17, 2015.

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Company Profile

This profile covers Osachi Co Ltd based in Okaya, Japan.

FDA Inspection History

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

First inspected August 9, 2012. Last inspected September 17, 2015.

Most cited issue areas

  • Design verification - documentation1 inspection
  • DHR - not or inadequately maintained1 inspection
  • Documentation1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
September 17, 2015NAIMedical Devices & Rad Health · Compliance: Devices942209
August 9, 2012OAIMedical Devices & Rad Health · Compliance: Devices796660
FDA documents

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

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Company Information

Name

Osachi Co Ltd

FEI Number

3004475751

Address

9-11, Osachikohagi, Okaya, Japan

Country

Japan

ID: 58d8e12a-ca60-4c96-8694-52c4dbe10f25

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