FDA inspection

Mary Jane Opperman Women's Diagnostic Center: FDA inspection ending May 15, 2017

FDA inspection 1011518 · Grosse Pointe Farms, MI

Key facts

Inspection ID 1011518
Firm Mary Jane Opperman Women's Diagnostic Center
FEI number 1000518290
Address 159 Kercheval Ave
City Grosse Pointe Farms
State MI
ZIP 48236-3610
Fiscal year 2017
Inspection end date May 15, 2017
Project area Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography Qual Stand Act (MQSA) Auth|Mammography 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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
  • 10–99 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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