FDA Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.

Carolina Liquid Chemistries was on the receiving end of the most recently announced warning letter, which contends that the Greensboro-based firm sold Class I and II in vitro diagnostic (IVD) reagents without obtaining the necessary premarket approval. More specifically, Carolina Liquid failed to produce evidence showing that distributions of Tapentadol, Zolpidem, Spice and Fentanyl reagents branded only for forensic or research and development were restricted to appropriate research centers, law enforcement agencies or court mandated testing centers. The agency suspects that the reagents might have also been sold to pain management centers and a clinical testing laboratory for unapproved clinical testing applications. The FDA raised concerns about the sales history of Carolina Liquid reagents branded as for forensic and research use while inspecting the company’s facilities last year.

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