483
Inventus Power Design CenterInventus Power Design Center – FDA 483, Apr 8, 2019
Record Details
An FDA inspection of Inventys Power Design Center, a Class II medical device manufacturer in Guangzhou City, China, revealed a significant issue with design verification documentation. The firm failed to properly document and file design verification results, specifically lacking raw data to support verification reports. This indicates a deficiency in their design history file management.
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