AHPA Asks FDA to Change its 483s Process

Silver Spring, MD—The American Herbal Products Association (AHPA) has petitioned the U.S. Food and Drug Administration to change how it writes Form 483s.

Form 483s are a normal part of the FDA good manufacturing practices (GMPs) inspection process for food and supplements plants. After visiting a facility, inspectors describe their observations and requirements for changes on the form, but they cannot name which specific regulation was in violation.

On October 17, AHPA submitted a Citizen Petition asking for this to change. Specifically, AHPA was FDA to name which regulation applies to each observation on the form, which “would assist the regulated industry in coming into compliance with FDA regulations and thereby promote the rationale underlying their promulgation.”

AHPA points out that FDA Inspections Operations Manual does not explain why FDA should withhold these references, and that adding such information should not create more work for inspectors.

Published in WholeFoods Magazine, December 2013 (online 10/28/13)