FDA 483 - Laurus Labs Limited - August 18, 2017

Laurus Labs Limited in Visakhapatnam, India, was cited for significant deficiencies in its Out of Specification (OOS) investigations, including invalidating results without scientific justification and failing to follow established procedures. Additionally, the firm's laboratory instrument qualification was found deficient, leading to corrupted and irretrievable audit trail files for a critical Particle Size Distribution instrument. These issues indicate serious concerns regarding data integrity and quality control practices.