Successful FDA Inspection at Gerresheimer Medical Plastic Systems Dongguan in China

17-Sep-2012 - China

Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA-inspected medical device manufacturer for the production of a new inhaler. As part of the product’s drug approval on the American market, the entire value creation chain was carefully examined in accordance with the strictest standards.

The inspection’s success has shown that the Chinese facility of Gerresheimer MPS can pass the inspection of all quality inspections. Bernd Stenzel: (Director Quality Management, Gerresheimer Regensburg GmbH, Wackersdorf) is proud of the result: “The inspection shows that our efforts over the past few years to develop a robust management system have been successful and that we can demonstrate compliance with all applicable rules and standards.”

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