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

Curia New York, Inc. in Rensselaer, NY, an API manufacturer, received a Form 483 with 10 observations during an inspection from 01/28/2026 to 02/05/2026. The observations primarily highlight significant data integrity issues, including missing signatures on laboratory records, lack of traceability for electronic data, destruction of original QC records, shared login credentials, and mismatched employee signatures. Additionally, the firm was cited for inadequate quality unit oversight, unverified yield calculations, poorly maintained clean rooms, and improper equipment maintenance and documentation.