# FDA 483 - Solaris Pharma Corp - April 21, 2026

Source: https://www.keypedia.com/records/483/solaris-pharma-corp/1fdd1dbe-84f4-44e9-9138-c3b74a20f81c

> FDA 483 for Solaris Pharma Corp on April 21, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Solaris Pharma Corp
- Inspection Date: 2026-04-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Scinopharm Pharma Corporation in Somerset, NJ, was cited for significant deficiencies in its quality control capabilities for commercial drug manufacturing. The inspection revealed that the QC laboratory is still under construction and non-functional, essential analytical instruments are missing and unqualified, and analytical methods and procedures are not yet validated or approved by quality assurance. These issues indicate a lack of readiness for commercial production.

## Related Documents

- [483 - 2019-10-31](https://www.keypedia.com/records/483/solaris-pharma-corp/e583753a-c336-463d-90cf-63c98c7a3038)
- [483 - 2025-09-18](https://www.keypedia.com/records/483/solaris-pharma-corp/fe991640-a274-463f-a0eb-43b67bda9203)

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

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