FDA 483 - Analys Lab Private Limited - December 20, 2024

Analys Lab Private Limited (TIE Campus) in Medchal Malkajgiri, India, a control testing laboratory, was cited for deficiencies in computer system controls. The inspection revealed a lack of user privilege challenges in LabSolutions software, allowing unauthorized deletion of data, and inadequate audit trail review procedures. These issues indicate significant concerns regarding data integrity and control over electronic records.