# FDA 483 - Stratus BioSystems, LLC - June 11, 2024

Source: https://www.globalkeysolutions.net/records/483/stratus-biosystems-llc/fd4e904f-c002-45ad-a9db-0038b29266e9

> FDA 483 for Stratus BioSystems, LLC on June 11, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stratus BioSystems, LLC
- Inspection Date: 2024-06-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Stratus BioSystems, LLC, an HCT/P manufacturer in Grapevine, TX, was inspected from June 3-11, 2024. The inspection revealed a significant deficiency in process validation procedures for their AmnioAMP-MP amniotic membrane product. Specifically, the firm failed to establish and document the allowable hold times for the membrane during manufacturing, leading to concerns about product quality and expiration dating.

## Related Documents

- [WARNING_LETTER - 2019-02-28](https://www.globalkeysolutions.net/records/warning_letter/stratus-biosystems-llc/b743b7c5-76b5-455f-b328-acbdb6761350)
- [483 - 2021-11-10](https://www.globalkeysolutions.net/records/483/stratus-biosystems-llc/237d3e14-4105-4957-a643-25f128fa032a)
- [WARNING_LETTER - 2021-11-10](https://www.globalkeysolutions.net/records/warning_letter/stratus-biosystems-llc/0b15ce19-51b1-4796-95b2-1380744e8cb2)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

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

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