FDA 483 - Stira Pharmaceuticals LLC - November 05, 2021

Atira Pharmaceuticals, LLC in Fairfield, NJ, a control testing laboratory, was inspected from October 27 to November 5, 2021. The inspection revealed significant deficiencies in computer system controls and software validation for laboratory equipment. These issues led to concerns regarding data integrity, as raw data files were accessible and deletable without proper audit trail capture or traceability.