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Home » US FDA, Renovo at loggerheads over added sterilization inventory
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US FDA, Renovo at loggerheads over added sterilization inventory

April 5, 2024
By Mark McCarty
Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.
BioWorld MedTech Regulatory U.S. FDA

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