FDA warns Medtronic’s Tyrx on anti-bacterial envelopes

The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. 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 enve...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Regulatory/Compliance Surgical Medtronic TYRX Inc. Warning Letter Source Type: news