# FDA 483 - Geneoscopy, Inc. - May 17, 2023

Source: https://www.keypedia.com/records/483/geneoscopy-inc/eef640cb-6371-41f2-9e21-44671ea01958

> FDA 483 for Geneoscopy, Inc. on May 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geneoscopy, Inc.
- Inspection Date: 2023-05-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Geneoscopy, Inc., a medical device manufacturer in Saint Louis, MO, identified two significant observations related to quality system procedures. The firm failed to establish procedures for finished device acceptance and adequately establish procedures for device history records, specifically concerning their Stool Sample Collection kits. These issues indicate deficiencies in ensuring proper control and documentation of medical device manufacturing and release.

## Related Documents

- [483 - 2025-05-14](https://www.keypedia.com/records/483/geneoscopy-inc/1a0f8863-19b3-4bc7-b2c1-02cf36cc3ae3)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8