483
Lambda Therapeutic Research Ltd.Lambda Therapeutic Research Ltd. – FDA 483, Jan 20, 2020
Record Details
During an inspection, Lambda Therapeutic Research, Ltd., a Contract Research Organization in Ahmedabad, India, was cited for failing to report complete precision data for anti-drug and neutralizing antibody assays. This single observation indicates a concern regarding data integrity and reporting practices in method validation. The firm did not include all generated precision data from specific runs for two key assays associated with clinical studies.
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ID · fc019d06-f560-458a-bfc2-c5291b7ab3b6
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