HHS NEWS
U.S. Department of Health and Human Services
NOTE TO CORRESPONDENTS Bradford Stone: (301) 443-3285
March 26, 1997
Consumer Hotline:(800) 532-4440
FDA TO PROVIDE FIRMS WITH FINAL INSPECTION REPORTS
Starting in April 1997, FDA will automatically provide firms
that have been inspected with a copy of the agency's final report
-- establishment inspection report (EIR) -- of the firm's
facility. The EIR will be provided as soon as the agency has
determined that the inspected firm's facility is in compliance
with FDA rules and guidelines.
This new FDA policy eliminates the need for the inspected
facility to request these reports through formal Freedom of
Information Act procedures and should provide them with quicker,
easier access to useful information about the inspection. FDA
undertook this action directly in response to comments from
industry trade associations that their members could benefit from
more timely access to these reports.
This action is part of the agency's overall effort to
enhance its regulatory efficiency and to reduce unnecessary
burdens on industry.
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