Review of the Food and Drug Administration's ... - OIG .HHS .gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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From / Inspector General

Office of Inspector General

Memorandum

Subject

Review of the Food and Drug Administration's Inspection Process of Plasma Fractionators (CIN: A-03-97-O0350)

To

Michael A. Friedman, M.D.

Lead Deputy Commissioner

Food and Drug Administration

The attached final report provides the results of our review of the Food and Drug Administration's (FDA) inspection process of plasma fractionators. This review was performed at the request of the Chairman, Subcommittee on Human Resources, House Committee on Government Reform and Oversight.

The Subcommittee specifically asked us to examine concerns regarding FDA's: effectiveness in conducting inspections of plasma fractionators; communication of a plasma product recall; and handling of an industry-wide plasma saline contamination problem.

On June 3, 1997, we received FDA's comments on our findings and recommendations. We have incorporated these comments where appropriate.

Our work was conducted under an unusually tight time frame, and we appreciate FDA's efforts to help us complete our report in a timely manner. We would like to be advised of any further action taken or contemplated on our recommendations within the next 60 days. If you have any questions, please call me or have your staff contact Joseph J. Green, Assistant Inspector General for Public Health Service Audits, at (301) 443-3582.

Attachment

Department of Health and Human Services

OFFICE OF' INSPECTOR GENERAL

REVIEW OF THE

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FOOD AND DRUG ADMINISTRATION'S

INSPECTION PROCESS OF

PLASMA FRACTIONATORS

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