FDA One Tray Warning Letter

The FDA has issued a warning letter to Innovative Sterilization Technologies, LLC (IST) in regards to use of One Tray use for terminal sterilization and storage. The FDA letter and IST response can be found here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019;

https://docs.wixstatic.com/ugd/903bd4_3c98dc3940584939ad621d7596af9875.pdf

Please review your facility processes, documentation and risk assessments.