ARROW-KONTRON INTRA-AORTIC PUMP PROCEDURES VIOLATE GMP, MDR REGS
This article was originally published in The Gray Sheet
Executive Summary
ARROW-KONTRON INTRA-AORTIC PUMP PROCEDURES VIOLATE GMP, MDR REGS, FDA said in a June 22 warning letter. The agency's letter follows a February inspection of the firm's Everett, Massachusetts facility that found deficiencies in good manufacturing practices and medical device reporting.