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Firms Should Ensure Agreement Between Corporate and Site-Specific Policies

December 21, 2007

Firms Should Ensure Agreement Between Corporate and Site-Specific Policies
To avoid potential problems during FDA inspections, manufacturers should consider harmonizing their corporatewide policies with policies specific to individual manufacturing sites, according to a former FDA investigator.

“One of the things I liked to do as an inspector … is to look for the discrepancies or differences between corporate polices and the individual site policies. And there always are [discrepancies],” Michael Beatrice, vice president of corporate regulatory and quality science at Abbott Laboratories, said at the Second Annual FDA Inspections Summit.

During his time as an investigator at the FDA, Beatrice said he inspected virtually every major manufacturer in the U.S. and noticed corporate policies often are complicated and contradict local site policies.

Abbott is simplifying many of its central policies so sites can adapt specific local requirements to their operations without conflicting with corporate policy, Beatrice said. The firm has 17 Tier I corporate policies covering areas such as design validation, management review and corrective and preventive actions.

He also advised firms that the FDA’s policy on repeat Form 483 observations has changed. If a firm is cited for a facility in Iowa and subsequently cited for the same violation in China, the agency will view that as a repeat observation.