Geneoscopy, Inc.May 14, 2025

FDA 483 - Geneoscopy, Inc. - May 14, 2025

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Genescopv, Inc., a manufacturer of in vitro diagnostic products in Saint Louis, MO, was cited for failing to manufacture products in accordance with good manufacturing practices. The firm was observed using laboratory consumables labeled "Research use only" for at-home diagnostic screening tests of patient samples. This practice indicates a significant deviation from the Quality System Regulation.

Company: Geneoscopy, Inc.
Inspection Date: May 14, 2025
Product Type: Device
Office: Kansas City District Office
People: Edward E. Lockwood
Shawn Choi

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ID · 1a0f8863-19b3-4bc7-b2c1-02cf36cc3ae3