Solvias USA, LLC – FDA 483, Jul 16, 2026

Solvias USA, LLC, a contract testing laboratory in Canton, MA, received an FDA Form 483 citing deficiencies in data integrity and audit trail review. The firm failed to ensure that input and output from computerized systems and records were checked for accuracy, specifically regarding the consistent review and documentation of audit trails for HPLC systems used in CGMP testing. These issues indicate significant concerns with the firm's data management and record-keeping practices for commercial drug product analysis.