top of page
Search
  • Writer's pictureKBM
    • Sep 24, 2019
    • 1 min read

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;

Please review your facility processes, documentation and risk assessments.



42 views0 comments

Recent Posts

See All

Have You Evaluated Your Patient Care Contracts?

This article begins to highlight the need for effective contract performance documentation and evaluation. You must place specific, measurable, attainable, relevant, and timely (SMART) key performanc

Post: Blog2_Post
bottom of page