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US FDA Inspection - Janvier 2019

In January, Medistri has hosted its third US FDA Inspection in 5 years. It is very important for us to provide the best service in term of quality, reliability but also Regulatory Compliance. 

As a contract steriliser company, we are a critical step for the release of our customer’s products and we are considered as manufacturers, which means we need to be registered with different authorities such as FDA.

The investigator was very experienced, with many years “on the field” of Inspections. He was satisfied with our processes and confirmed compliance with the requirements of 21 CFR part 820.

Please, visit our website https://www.medistri.swiss/en/downloads to find all our certificates and if you have any questions regarding our Registrations, please contact quality@medistri.swiss, our team will be pleased to answer your questions.”