Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Industry about sterility issues with medical devices processed at the Steril Milano S.R.L.’s Reggiolo and Monza ethylene oxide sterilization facilities. The FDA became aware that Steril Milano falsified sterilization certificates for a variety of FDA-regulated products dating back to 2016. 

The FDA is working with medical device manufacturers, international partners, and U.S. federal partners to investigate the scope of medical devices that may be impacted and intends to contact potentially impacted firms that are known to have contracted medical device sterilization services with these Steril Milano facilities. 

Questions? 

If you have questions about this Letter to Industry, contact the Division of Industry and Consumer Education (DICE). 

For questions about imports, please email FDAImportsInquiry@fda.hhs.gov.