483
PETNET Solutions, IncPETNET Solutions, Inc – FDA 483, Sep 23, 2016
Record Details
An FDA inspection of PETNET Solutions, Inc. in Royal Oak, MI, revealed that the firm's laboratory analytical methods are not sufficiently specific or accurate. Specifically, issues were noted with the software's inability to identify and integrate main peaks during FDG purity testing, leading to invalid results. This indicates a significant quality control deficiency in their analytical processes.
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ID · f502e1ae-b44d-4260-b3e5-6cc85f8f6a4f
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