483
Di-Chem IncFDA 483 - Di-Chem Inc - February 13, 2020
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Record Details
An FDA inspection of Di-Chem Inc, a medical device manufacturer in Champlin, MN, revealed two significant quality system deficiencies. The firm failed to conduct management reviews of its quality system for two consecutive years and allowed individuals with direct responsibility for audited matters to conduct internal quality audits.
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ID · 64c4da9a-412d-4220-b2ab-f9ac70d18a5d