Home » Warning to Chinese Devicemaker Cites Documentation for Pilot Runs
Warning to Chinese Devicemaker Cites Documentation for Pilot Runs
Vincent Medical lacked appropriate documentation for its pilot runs of a product, according to a Sept. 5 warning letter posted recently online. The Chinese company manufactures breathing circuits and sterile fluid management injection systems. Vincent’s product design and development procedure requires mass production runs, or “pilot runs,” to ensure products can meet their intended use.
The GMP Letter
The GMP Letter
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