FDA adds ethylene oxide sterilized medical devices processed at Steril Milano facilities in Monza and Reggiolo, Italy to Import Alert 89-04
Published Jun 10, 2021
Summary
FDA has added ethylene oxide sterilized medical devices processed at Steril Milano facilities in Monza and Reggiolo, Italy to Import Alert 89-04 due to sterility issues and falsified certification records. The notice advises importers on documentation to submit via ITACS if entries are held at the port of entry.
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