483
Agada Biosciences CorpFDA 483 - Agada Biosciences Corp - March 09, 2020
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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.
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