News about GMP/cGMP

07.06.2021

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.

The two facilities of the Italian company Steril Milano S.r.L. in Monza and Reggiolo have closed their doors since March 2021. The company, which offers a sterilization service for medical devices, is facing serious allegations of manipulation. In the meantime, Steril Milano S.r.L's certificate has been withdrawn by the responsible accreditation body.


The Center for Devices and Radiological Health (CDRH) issued a warning to about 100 medical device manufacturers: the products may, to a significant extent, not be sufficiently sterilized by Steril Milano. In the meantime, this has led to various product recalls in the USA. A variety of medical device types may be affected, including biopsy needles, syringes, catheters, intravascular administration sets and arthroscopes.

The German BfArM and the US FDA have both called on manufacturers and distributors of medical devices to check whether their products are associated with Steril Milano and to report this if necessary.

Additionally, the FDA has issued an import ban in the U.S. on medical devices manufactured at Steril Milano facilities. 


Source:

FDA: Industry (Medical Devices)

BfArM: Empfehlungen


 

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