483
CellTrans, Inc.CellTrans, Inc. – FDA 483, May 6, 2021
Record Details
An FDA inspection of CellTrans, Inc. in Chicago, IL, identified one observation related to clinical trial documentation. The firm, acting as a sponsor, failed to include the complete required ClinicalTrials.gov statement in informed consent documents for five subjects. This indicates a deficiency in adhering to regulatory requirements for clinical trial transparency and subject information.
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ID · 89bad219-38ce-44a8-81d3-1236f579e7a5
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