483
Linda GlaserLinda Glaser – FDA 483, Sep 20, 2010
Record Details
Coastal Biomedical Research, Inc. in Santa Monica, CA, was cited for significant deficiencies during an FDA inspection of its clinical trial operations. The firm failed to maintain adequate investigational drug disposition records, exhibited multiple protocol deviations, and did not ensure accurate case histories for study subjects. These issues indicate serious concerns regarding data integrity and adherence to clinical trial regulations.
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ID · 02f0a1d2-0da0-427d-8853-9e5f62943026
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