# FDA 483 - Solaris Pharma Corp - September 18, 2025

Source: https://www.keypedia.com/records/483/solaris-pharma-corp/fe991640-a274-463f-a0eb-43b67bda9203

> FDA 483 for Solaris Pharma Corp on September 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solaris Pharma Corp
- Inspection Date: 2025-09-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2019-10-31](https://www.keypedia.com/records/483/solaris-pharma-corp/e583753a-c336-463d-90cf-63c98c7a3038)

## Related Officers

- [Brandy D. Brown](https://www.keypedia.com/people/brandy-d-brown/667c6b9a-6ab9-42d4-b364-a96207bca072)

Company: https://www.keypedia.com/companies/solaris-pharma-corp/2730f83a-223f-4ef6-95e1-4e3b069342ce

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248