483
Imediplus Inc.Imediplus Inc. – FDA 483, Feb 22, 2019
Record Details
Imediplus Inc., a medical device manufacturer in Chupei City, Taiwan, received two observations during an FDA inspection. The inspection revealed deficiencies in design validation, specifically regarding the documentation of test equipment used for software validation. Additionally, the firm failed to include descriptions of changes in its records for various critical documents.
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ID · 20015565-bb04-4492-8805-9befbcc57e3f
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