During an inspection of your firm located in Tuttlingen, Germany, on January 25, 2012, through January 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-powered endoscopic grasping/cutting instruments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.