FDA 483 - Rubicon Research Private Limited - March 08, 2024

Rubicon Research Private Limited, a drug manufacturer in Thane, India, was cited for inadequate cleaning procedures during an FDA inspection. The firm's capping machine cleaning method was found to be insufficient, leading to the observation of foreign residue on drug product containers. This indicates a potential risk to the safety, identity, strength, quality, or purity of the drug products.