The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Effective March 21, 2016, FDA released updates to the guidance Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Specifically, the document addresses an...
We have been seeing more requests than ever for bacterial endotoxin testing on tissue and tissue based products. Currently the FDA does not require endotoxin testing of tissue, but there are relevant USP documents. The primary focus of USP <1046> Cellular and...
