# FDA 483 - Sentio Biosciences LLC - April 19, 2019

Source: https://www.globalkeysolutions.net/records/483/sentio-biosciences-llc/2f99fae6-de19-4496-beba-b98deb359299

> FDA 483 for Sentio Biosciences LLC on April 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sentio Biosciences LLC
- Inspection Date: 2019-04-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Sentio BioSciences LLC, a manufacturer in Maryland Heights, MO, revealed significant deficiencies in their quality systems. Observations included inadequate written procedures for equipment qualification, failure to follow established procedures for out-of-specification results and stability studies, and a lack of label specimens in batch manufacturing records. These issues indicate a need for improved control over manufacturing processes and documentation.

## Related Documents

- [483 - 2024-02-06](https://www.globalkeysolutions.net/records/483/sentio-biosciences-llc/c7c1a696-85a1-4f44-bab0-cef58ce91d71)

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

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