The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx, which Medtronic acquired for $160 million in January 2014, won CE Mark approval in the European Union for use with cardiac devices in September 2014.
The FDA said inspections at Tyrx’s Monmouth Juntion, N.J. plant from Nov. 30 last year to Feb. 12 turned up several problems. The federal safety watchdog issued a so-called Form 483, listing the violations found during the inspection, but found that Tyrx’s responses in March, April and May were inadequate, according to the June 2 warning letter.
The violations included “a process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated,” failure to “adequately establish procedures for corrective and preventive action” for envelopes that might have nonconformities, specifically out-of-specification results for drug content and low molecular weight in the Tyrosine polymer used to make the envelopes, according to the letter.
“Your firm needs to control and take action on devices distributed, and those not yet distributed, that are suspected of having potential nonconformities,” New Jersey acting district director Craig Swanson wrote.
The FDA inspection also found that Tyrx failed “to establish and maintain procedures for changes to a specification, method, process, or procedure where such changes shall be verified or where appropriate validated, Swanson wrote.
Medtronic had 15 days from receiving the letter to respond with the actions it’s taken to correct the violations, “including an explanation of how you plan to prevent these violations, or similar violations, from occurring again,” he wrote.