483
Ophtec USA, Inc.FDA 483 - Ophtec USA, Inc. - June 24, 2022
Record Details
An FDA inspection of Ophtec USA, Inc. in Sunrise, FL, a commercial sponsor-monitor, revealed one observation. The firm failed to consistently submit current lists of investigator names and addresses to the FDA at required intervals after investigation approval. This indicates a lapse in regulatory reporting for clinical investigations.
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ID · be0a44cd-f063-4bed-b27a-72a6ce4f0ca0
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