FAR Below Par Medical Device Company - Avis employé Engineer SurModics

Why the FDA had not yet cracked down on this company is beyond me! Training consists of simply signing a form on a project,(to appear to appease the FDA), without ANY real formal training! Yet the employee is held fully accountable for the results and the "quality"! If the FDA REALLY knew how they ran this business, they would shut them down in a heartbeat. They cheat and hide procedures when they know that the FDA is going to do an audit. Lead weights used to hold catheters in position while coating! (Well folks, lead is a poison!) The FDA direly needs to very closly investigate SurModics With a very fine tooth comb! Medical Device companies should avoid SurModics at all costs, or you may be pulled down with them by the FDA & ISO!!!!!