483
Antares Pharma, IncFDA 483 - Antares Pharma, Inc - May 13, 2022
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An FDA inspection of Antares Pharma, Inc. in Minnetonka, MN, a human drug and medical device manufacturer, identified one observation. The firm was cited for not adequately establishing procedures for design changes, specifically regarding functional testing for subassembly release without proper validation or objective evidence.
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