FDA 483 - RUBICON RESEARCH LIMITED - January 27, 2023

Rubicon Research Private Limited, a liquid oral dose finished drug manufacturer in Satara, India, was cited for significant deficiencies during an FDA inspection. The observations include inadequate laboratory controls for out-of-specification results, incomplete validation of critical manufacturing processes like bottle sealing, and plumbing system defects that pose a contamination risk. These issues indicate potential compromises to drug product quality and purity.