483
Solaris Pharma CorpFDA 483 - Solaris Pharma Corp - September 18, 2025
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Record Details
Solaris Pharma Corp in Somerset, NJ, was inspected regarding its Periodic Adverse Drug Experience (PADE) reporting. The inspection revealed that the firm failed to submit several annual periodic adverse drug experience reports within the required 60-day timeframe. This indicates a lapse in timely regulatory compliance for drug safety reporting.
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