Utah Medical’s 483
This article was originally published in The Gray Sheet
Executive Summary
Response to FDA quality system inspection observations (form FDA-483) addresses an alleged lack of injection molding and extrusion operation validation, the firm says. The Salt Lake City firm, which has pending lawsuits against FDA seeking access to export certificates that have been denied due to alleged QS/GMP non-compliance dating to 2001, asserts it "has been and is in compliance with a reasonable interpretation" of FDA quality system regulations (1"The Gray Sheet" March 1, 2004, p. 14). The Feb. 2 through March 3 inspection report does not cite a lack of sterilization validation or failure to follow MDR report procedures, as was alleged after a 2003 inspection, the firm claims. "There were no current observations to suggest or support concern" about device safety or effectiveness, Utah says...
You may also be interested in...
Utah Medical Sues FDA For Export Certificates Denied Over GMP Findings
Utah Medical cites FDA's refusal to engage in "meaningful" dialogue about alleged good manufacturing practice deficiencies since 2001 as the origin of a dispute that has yielded two lawsuits against the agency
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.