FDA 483 - INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED - December 18, 2025

Invitro Research Solutions Private Ltd, a control testing laboratory in Bengaluru, India, was cited for significant deficiencies in its laboratory controls and quality systems. Observations included incomplete laboratory records for method validation, inadequate investigations into failed analyses, and a lack of sufficiently detailed written procedures for various production and process controls. The firm also failed to demonstrate the specificity of its in-house method for analyzing stability samples.