THE ONE TRAY® FDA WARNING LETTER – CLOSED

OFFICIAL COMPANY STATEMENT: Innovative Sterilization Technologies (IST/ ONE TRAY®) is pleased to announce the closure of the FDA Warning Letter. After many years of working with the FDA on this very unique product’s clearance, we are happy our storage claim, which has been there from the beginning, has been acknowledged by the FDA. ONE TRAY® was cleared with a validated 48 hour storage period. We strive to support and educate our customers, as well as the industry, regarding the ONE TRAY® technology and its’ usage.  

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In collaboration with Innovative Sterilization Technologies (IST/ ONE TRAY®)


Explore this page and find more information regarding the closure of the Warning letter plus general educational information on the ONE TRAY® technology. If you would like to reach out to us for any reason, please send us a message, or call 937.619.0138.

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