483
Antares Pharma, IncAntares Pharma, Inc – FDA 483, May 13, 2022
Record Details
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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