FDA Using GMP Head Count Method That May Shorten Compliance Schedules
This article was originally published in The Tan Sheet
Executive Summary
Despite industry opposition, FDA will likely stick with an approach to assessing a firm's size that would count some small or medium-sized dietary supplement firms as larger, significantly shortening their schedule to comply with dietary supplement good manufacturing practices, officials say
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FDA says it will count only a firm's "direct employees" when determining its compliance deadline under the dietary supplement good manufacturing practices final rule
In Reversal, FDA Will Leave Contractors Out Of GMP Head Counts
FDA says it will count only a firm's "direct employees" when determining its compliance deadline under the dietary supplement good manufacturing practices final rule