# FDA 483 - Stratus BioSystems, LLC - November 10, 2021

Source: https://www.keypedia.com/records/483/stratus-biosystems-llc/237d3e14-4105-4957-a643-25f128fa032a

> FDA 483 for Stratus BioSystems, LLC on November 10, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stratus BioSystems, LLC
- Inspection Date: 2021-11-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Stratus BioSystems, LLC was cited for significant deficiencies in its manufacturing of injectable products derived from human gestational tissues. The inspection revealed a lack of a quality control unit, inadequate aseptic processing validation, and insufficient environmental monitoring. Furthermore, the firm failed to investigate sterility failures, validate cleaning processes, and properly test donors for cytomegalovirus, indicating severe control and quality assurance issues.

## Related Documents

- [WARNING_LETTER - 2019-02-28](https://www.keypedia.com/records/warning_letter/stratus-biosystems-llc/b743b7c5-76b5-455f-b328-acbdb6761350)
- [WARNING_LETTER - 2021-11-10](https://www.keypedia.com/records/warning_letter/stratus-biosystems-llc/0b15ce19-51b1-4796-95b2-1380744e8cb2)
- [483 - 2024-06-11](https://www.keypedia.com/records/483/stratus-biosystems-llc/fd4e904f-c002-45ad-a9db-0038b29266e9)

## Related Officers

- [Investigator](https://www.keypedia.com/people/abby-l-mozeke-baker/32e2896f-b836-4752-862e-de98370b8cad)
- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/stratus-biosystems-llc/19f91252-2572-4e95-af09-c6ab599ed544

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab