GMP Warnings Reflect Firms’ Lack Of Commitment – Fabricant
This article was originally published in The Tan Sheet
Executive Summary
FDA inspectors continue to find good manufacturing practice violations of a basic, rather than technical, nature. The director of the agency’s Division of Dietary Supplement Programs hammered the point home to an industry audience May 2.
You may also be interested in...
Sunset Natural Injunction Continues Rise In DoJ Supplement GMP Complaints
After litigating six civil complaints in 2014, DoJ’s uptick in bringing criminal and civil cases concerning supplement GMP violations in 2015 comes with the industry’s Senate champions, Orrin Hatch, R-Utah, and Martin Heinrich, D-NM, urging prosecutions against marketers of spiked products.
Sunset Natural Injunction Continues Rise In DoJ Supplement GMP Complaints
After litigating six civil complaints in 2014, DoJ’s uptick in bringing criminal and civil cases concerning supplement GMP violations in 2015 comes with the industry’s Senate champions, Orrin Hatch, R-Utah, and Martin Heinrich, D-NM, urging prosecutions against marketers of spiked products.
ForMor Challenges FDA On Own-Label Supplement GMP Stance
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.