FDA 483 - Laurus Labs Limited - January 31, 2025

During an inspection conducted from January 27 to January 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to Laurus Labs Limited, an API manufacturer located in Anakapalli District, Andhra Pradesh, India. The primary issue identified by investigators Jessica S Estriplet and Olumide A Akinyemi was the firm"s failure to ensure that written procedures, particularly equipment qualification protocols, were appropriately drafted, reviewed, and approved by the quality control unit. Specifically, multiple pieces of equipment used in the manufacturing of active pharmaceutical ingredients (APIs) were observed to have undergone qualification (Installation, Operational, and Performance Qualification) without prior approval of their respective protocols by the quality unit. This observation highlights a deficiency in the company"s adherence to established quality system requirements for manufacturing controls. Laurus Labs Limited is expected to address this observation by implementing corrective actions to ensure all equipment qualification activities are governed by properly approved protocols and that all relevant procedures meet regulatory expectations.