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

Source: https://www.keypedia.com/records/483/geneoscopy-inc/1a0f8863-19b3-4bc7-b2c1-02cf36cc3ae3

> FDA 483 for Geneoscopy, Inc. on May 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geneoscopy, Inc.
- Inspection Date: 2025-05-14
- Product Type: device
- Office Name: Kansas City District Office
- Summary: 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.

## Related Documents

- [483 - 2023-05-17](https://www.keypedia.com/records/483/geneoscopy-inc/eef640cb-6371-41f2-9e21-44671ea01958)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/geneoscopy-inc/b70bf3df-90bb-48eb-8f65-c2cb50441be4

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79