FDA 483 - Curia New York, Inc. - February 05, 2026

An FDA inspection of Curia New York, Inc. in Rensselaer, NY, revealed significant data integrity and quality control deficiencies. Observations included missing signatures on laboratory data, lack of traceability for electronic data, and the destruction of original QC records. Additionally, issues with shared login credentials, inconsistent employee signatures, unverified batch yield calculations, and inadequate facility and equipment maintenance were noted, indicating systemic breakdowns in quality assurance and good manufacturing practices.