TriMed, Inc., an orthopedic medical device developer and manufacturer for the treatment of the extremities through Open Reduction Internal Fixation (ORIF), announced it received a closeout letter from the Food and Drug Administration (FDA). The letter, dated October 11, 2019, successfully closes out the FDA’s 483 Warning Letter received in June 2016. The company said receipt of the letter also signals the completion of a 24-month initiative to expand and enhance quality management systems after receiving the 483.
The 24-month process significantly upgrades TriMed’s quality department and quality systems to align with industry best practices while continuing to deliver products to the highest standards. The focus includes more robust processes in documenting the activities of design controls, purchasing controls, material controls, risk management, corrective and preventive action (CAPA), and field actions.
In addition to the improvements in quality management systems, TriMed reorganized its Quality Management Department to ensure continued regulatory compliance and continuous improvements. Some of these expansions include staff additions, cross-trained staff responsible for handling all aspects of FDA and international regulations, and the addition of a supplier quality manager, with oversight of supplier quality and material dispositions. Richard Lubin, Director, Global Quality Assurance and Regulatory Affairs /Head of Quality, now leads TriMed’s quality and regulatory affairs efforts.
“We are confident these improvements mean continued patient safety and assurance for physicians who rely on our products. We remain dedicated to bringing innovative, state-of-the-art orthopedic solutions to the marketplace and patients,” said TriMed’s CEO, David Medoff.
About TriMed, Inc.:
TriMed, Inc, a leader in the advancement of innovative orthopedic fixation systems, are innovators in the field by redefining the treatment of periarticular fractures through ORIF. TriMed, headquartered in Santa Clarita, CA, holds numerous orthopedic device patents.
FOR MORE INFORMATION CONTAINED IN THIS RELEASE:
The FDA 483 Warning Letter is located on the FDA site at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trimed-inc-06302016
The FDA 483 Closeout Letter is located on the FDA site at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trimed-inc-494255-10112019