483
AMPLIFY BIOAMPLIFY BIO – FDA 483, Aug 5, 2021
Record Details
AMPLIFY BIO, a non-clinical laboratory in West Jefferson, OH, received a Form 483 with three observations. The inspection revealed that nonclinical studies were not conducted according to protocol, specifically concerning animal age. Additionally, the firm failed to properly identify specimens with collection dates and lacked established procedures for handling test and control articles to prevent contamination.
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ID · eccfceaf-f159-48f4-b15a-8e3f6b8caedc
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