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FDA perspective on “Where are we? Where can we go?” 12 th Annual FDA & the Changing Paradigm for Blood Regulation 16 January 2009 -- Las Vegas, NV

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FDA perspective on “Where are we? Where can we go?” 12 th Annual FDA & the Changing Paradigm for Blood Regulation 16 January 2009 -- Las Vegas, NV. Gilliam B. Conley Director, Division of Inspections & Surveillance FDA, Center for Biologics Evaluation & Research

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FDA perspective on “Where are we?Where can we go?”12th Annual FDA & the Changing Paradigm for Blood Regulation16 January 2009 -- Las Vegas, NV

Gilliam B. Conley

Director, Division of Inspections & Surveillance

FDA, Center for Biologics Evaluation & Research

Office of Compliance & Biologics Quality

introduction
Introduction

We will discuss

  • FDA inspection data
  • Fatalities reported to FDA
  • Biological Product Deviation Reports
  • Where (can) should we go?
top 10 blood blood component observations fy 2008 oct 07 through sept 08 continued
Top 10 Blood & Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08) - continued
top 10 blood blood component observations fy 2008 oct 07 through sept 08 continued7
Top 10 Blood & Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08) - continued
inspection classification fy 2008
Inspection Classification – FY-2008

Note: These numbers represent a snapshot in time from our inspections database. Because of the further routine review following an investigator’s initial recommendation for an OAI inspection decision, the year-end actual numbers are fewer than the 14 reported here.

regulatory actions fy 2008
Regulatory Actions – FY-2008
  • Warning Letters
    • 1 – Source Plasma
    • 3 – transfusion services or blood centers
  • Adverse Determination Letters
    • 1 – issued under consent decree covered multiple facility inspections

Find on the web:

WL - http://www.fda.gov/foi/warning.htm

ADL - http://www.fda.gov/ora/frequent/default.htm

where can should we go
Where (can) should we go?
  • We will continue to gather information
  • We will continue to report information(web based information, public presentations, …)
  • We are interested in learning:
    • How do you use FDA’s posted data?
      • Analyze with own data?
      • Institute quality change?
    • Which FDA-posted data is most useful?
    • What are your success stories?Please find a way to share with others
questions
Questions

Please join in the Q & A session

at the conclusion

of this morning’s session.

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