483
Zhangzhou Aoxi Plastics Co., Ltd.FDA 483 - Zhangzhou Aoxi Plastics Co., Ltd. - December 06, 2017
Record Details
An FDA inspection of Zhangzhou Aoxi Plastics Co., Ltd. in Zhangzhou, China, a medical device manufacturer, revealed a significant issue regarding process validation. The firm failed to adequately validate processes for manufacturing hospital disposable devices. This indicates a lack of assurance in the consistency and quality of their production methods.
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ID · 128590cd-9df6-4e4a-93e9-73c76709819d
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