Health Equipment Maker Midmark Gets FDA Warning Letter on Sterilizers
Published: Jan 05, 2012
Healthcare equipment supplier Midmark has received a warning letter from the U.S. Food and Drug Administration relating to the company’s manufacturing of steam sterilizers. Most of the violations listed by the FDA focus on record-keeping issues and manufacturing procedures by Versailles, Ohio-based Midmark. For example, in one violation, the company was cited for failing to monitor production processes to ensure that a device conforms to its specifications. In another violation, Midmark failed to maintain adequate records of acceptable suppliers, contractors and consultants for the sterilizers in question, according to the warning letter.