Medtronic MIS corrective actions bring firm back in compliance with GMPs -- FDA "close-out" letter.
This article was originally published in The Gray Sheet
Executive Summary
MEDTRONIC MICRO INTERVENTIONAL SYSTEMS' GMP PROCEDURES get a clean bill of health from FDA in a warning letter "close-out" correspondence sent to the company in late November, the firm says. FDA said in the letter that Medtronic MIS has corrected good manufacturing deficiencies identified by FDA in an Oct. 24 warning letter, including customer complaint handling, package seal inspection parameters and provisions for the reworking of defective packaging.