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09-18-2012

Gerresheimer: Successful FDA Inspection

Injection molding in an IS0 class 8 clean-room

Injection molding in an IS0 class 8 clean-room

Gerresheimer Medical Plastic Systems Dongguan Co., the Chinese facility of Gerresheimer MPS, Düsseldorf, Germany, 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 of the Food and Drug Administration (FDA) took place from August 14 - 17. The reason for this inspection was the new drug application (NDA) from a customer, which is preparing the market approval for a new inhaler plus drug at the American Food and Drug Agency. As part of the pre-approval inspection (PAI) of the Gerresheimer facility in Dongguan, the management system and the entire product production was inspected from incoming to outgoing goods. This includes the purchasing of rubber and metal parts, the injection molding process, the assembly and testing, the laser printing and the tamper-resistant sealing processes. The injection molding, assembly, inspection, and tamper-resistant sealing processes take place in a clean room of the ISO class 8.

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