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.