FDA Supplement GMP Warnings Cite Specification Failings
This article was originally published in The Tan Sheet
Executive Summary
Setting and confirming specifications for ingredients and for manufacturing processes continue to be a problem for dietary supplement firms, some of which fail to include adequate information on how they will remedy their problems when they respond to FDA inspectors’ findings.
You may also be interested in...
Undisclosed Allergen, Caffeine Claims Prompt Supplement Recalls
Firms marketing supplements found to contain steroid ingredients also are recalling products.
Executives On The Move: Changes At The Top At Enzolytics, Dyne Therapeutics And Seres Therapeutics
Recent moves in the industry include new chief financial officers at LENZ Therapeutics and Botanix Pharmaceuticals, plus new chief medical officers at Vigil Neuroscience and Voyager Therapeutics.
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.