# FDA 483 - Agada Biosciences Corp - March 09, 2020

Source: https://www.keypedia.com/records/483/agada-biosciences-corp/f7e3f533-1de5-4901-8685-fa1c7ca4769d

> FDA 483 for Agada Biosciences Corp on March 09, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agada Biosciences Corp
- Inspection Date: 2020-03-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AGADA Biosciences, a CRO, revealed two observations related to inadequate documentation and incomplete study reports. Specifically, the firm failed to record protein extract storage conditions and did not include all western blot analytical runs or reagent expiry dates in a study report. These issues indicate deficiencies in data integrity and reporting practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/arindam-dasgupta/4337d565-c1cb-4a78-aeae-f5afc35644d8)

Company: https://www.keypedia.com/companies/agada-biosciences-corp/426426b5-d764-4fb5-8acb-7d68c8cd34e2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd