The agency said that the deviations were related to Covidien’s, formerly Mallinckrodt’s, Ultra-TechneKow DTE (Technetium Tc 99m) generator, which was adulterated under various sections of the Food, Drug and Cosmetic Act.
According to the FDA letter, posted Tuesday, Covidien failed to establish appropriate standards and test procedures for the generator, specifically citing the company’s “failure to establish scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.” The agency listed four other qualifications that the Hamilton, Bermuda-based company needs to address.
Covidien was given 15 working days within the receipt of the letter to respond the FDA’s queries.
"Covidien is obviously treating this FDA warning letter very seriously, and we are committed to working closely with the FDA to resolve their concerns. We have cooperated fully with the agency during and after the inspection of our Maryland Heights manufacturing facility, responded to the warning letter in a timely manner, and will continue to comply with the actions that the FDA has requested,” JoAnna Schooler, spokesperson for Covidien, told Health Imaging News.
In related regulatory news, Covidien and Mallinckrodt notified healthcare professionals that two children with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 late last week.