483
PTC Therapeutics, Inc.FDA 483 - PTC Therapeutics, Inc. - November 18, 2024
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Record Details
An FDA inspection of PTC Therapeutics, Inc. in Warren, NJ, revealed a failure to ensure proper monitoring of a clinical study. Specifically, site monitoring did not adequately identify and document discrepancies in investigational product accountability as protocol deviations for non-compliant subjects. This indicates issues with clinical trial oversight and data integrity.
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ID · 8e4bd065-ca6a-4b5f-8e04-81589b640e0e