CarboFix Lands 483 for Quality Audits, Anti-Contamination
The FDA hit CarboFix Orthopedics on MDR submissions, anti-contamination efforts and quality audits.
The agency issued a Form 483 following a February/March inspection of the devicemaker’s Hamerkaz, Israel, facility. Investigators found the company failed to submit an MDR report within 30 days of becoming aware of potential malfunctions in a marketed device. Multiple complaints that could potentially qualify as adverse events were not reported, according to the form.
CarboFix also had no testing procedures for its implanted medical device for Endotoxin, a known contaminate, according to the FDA. Investigators further found that the facility did not perform quality audits at defined intervals.