Sterilization products maker STERIS Corp. (NYSE: STE) has received a warning letter from the Food and Drug Administration for quality control and record-keeping violations at a Texas plant.
The letter, dated Sept. 27 and addressed to STERIS CEO Walt Rosebrough, cited five violations at the company’s Grand Prairie, Texas, contract sterilization plant. The Mentor, Ohio, life sciences company operates 18 such plants in which it performs bulk sterilizations of other companies’ products, often medical devices, said Steve Norton, a STERIS spokesman. Contract sterilization falls under STERIS’ Isomedix business.
The company was instructed to take “prompt action” to correct the violations. Failure to do so could result in seizure, injunction or financial penalties. STERIS is working with the FDA to address the issues but hasn’t “closed it out yet,” Norton said.
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Warning letters generally are considered by the FDA to be informal and advisory. The letters are a fairly routine part of doing business for medical device firms. For the last year, STERIS has been dealing with another, far more serious issue with the FDA.
Last December, the FDA issued a safety alert about System 1, a sterilization system for heat-sensitive medical instruments, that cast a pall of financial uncertainty over the company. STERIS is working to transition customers to a new version of the product, called System 1E.
Norton said the Texas plant and System 1 issues were completely separate and involve different business units.
Many of the violations the FDA noted at the Texas plant were procedural. For example, STERIS was cited for failing to establish a procedure for how many humidity monitors should be placed in a load of finished medical devices that’s being sterilized. STERIS also was cited for failing to maintain records to show that device sterilization met the standards of its customers.
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STERIS has audited its other contract sterilization plants to ensure it’s not making the same errors as at the Texas plant cited by the FDA, Norton said.