# FDA 483 - StageBio - September 03, 2021

Source: https://www.globalkeysolutions.net/records/483/stagebio/8c52d123-69ce-42eb-abb0-3f828f280eb2

> FDA 483 for StageBio on September 03, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: StageBio
- Inspection Date: 2021-09-03
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: StageBio, a non-clinical laboratory in Frederick, MD, was inspected and received two observations. The inspection revealed the use of expired reagents in studies and the availability of expired reagents for use. Additionally, the firm lacked adequate written standard operating procedures for tracking study materials and controlling access to storage areas, which could impact data quality and integrity.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)

Company: https://www.globalkeysolutions.net/companies/stagebio/839d1a55-7810-466e-b202-efdae8782e4f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e