FDA inspection

IU Health Jay: FDA inspection ending Nov 5, 2019

FDA inspection 1116536 · Voluntary Action Indicated (VAI) · Portland, IN

Key facts

Inspection ID 1116536
Firm IU Health Jay
FEI number 1000518444
Address 500 W Votaw St
City Portland
State IN
ZIP 47371-1322
Fiscal year 2020
Inspection end date Nov 5, 2019
Classification Voluntary Action Indicated (VAI)
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 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 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 Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography 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Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) Authority|Mammography Quality Standards Act (MQSA) 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Product type Devices

At a glance

  • None Citations
  • 1–9 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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