Solaris Pharma CorpSeptember 18, 2025

FDA 483 - Solaris Pharma Corp - September 18, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Company: Solaris Pharma Corp
Inspection Date: September 18, 2025
Product Type: Drugs
Office: New Jersey District Office
Person: Brandy D. Brown

Open in Dashboard

ID · fe991640-a274-463f-a0eb-43b67bda9203