FDA inspection

Mikasa X-Ray Co., Ltd.: FDA inspection ending Sep 1, 2011

FDA inspection 749354 · No Action Indicated (NAI) · Bunkyo

Key facts

Inspection ID 749354
Firm Mikasa X-Ray Co., Ltd.
FEI number 3002807605
Address 5 Chome 10-5, Koishikawa
City Bunkyo
Fiscal year 2011
Inspection end date Sep 1, 2011
Classification No Action Indicated (NAI)
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Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act|Radiation Control and Health Safety Act (RCHSA) Authority
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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