FDA 483 - Solaris Pharma Corp - April 21, 2026

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.