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ForMor Challenges FDA On Own-Label Supplement GMP Stance

This article was originally published in The Tan Sheet

Executive Summary

ForMor contests a warning letter from FDA stating that as an own-label distributor, the firm is subject to both packager and labeler GMP requirements. The firm says it is only a “holder” of finished products and FDA bases its warning on the GMP rule preamble, not the actual rule.

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