# FDA 483 - Sentio Biosciences LLC - February 06, 2024

Source: https://www.globalkeysolutions.net/records/483/sentio-biosciences-llc/c7c1a696-85a1-4f44-bab0-cef58ce91d71

> FDA 483 for Sentio Biosciences LLC on February 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sentio Biosciences LLC
- Inspection Date: 2024-02-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Sentio Biosciences LLC in Maryland Heights, MO, revealed critical deficiencies in monitoring and controlling objectionable organisms within their (b)(4) system used for non-sterile API manufacturing. The firm's microbial test methods were not validated to detect Burkholderia cepacia complex, and a significant leak in the system went unaddressed for an extended period. These issues pose a high risk of microbial and chemical contamination to drug substances like Melarsomine Dihydrochloride and Pentosan Polysulfate Sodium.

## Related Documents

- [483 - 2019-04-19](https://www.globalkeysolutions.net/records/483/sentio-biosciences-llc/2f99fae6-de19-4496-beba-b98deb359299)

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.globalkeysolutions.net/companies/sentio-biosciences-llc/82a36049-123a-40d5-8acd-c2027748dc10

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