FDA EIR - RUBICON RESEARCH LIMITED - January 27, 2023

An FDA inspection of Rubicon Research Private Limited, located in Satara, India, took place from January 23 to 27, 2023. This initial inspection, focusing on non-sterile liquid drug manufacturing, revealed several deficiencies pertaining to the Food, Drug and Cosmetic Act's current Good Manufacturing Practices (CGMPs).

The inspection resulted in three key observations detailed in an FDA 483 form. Firstly, the company's laboratory procedures permitted reporting of passing re-test results as final data, even when initial out-of-specification (OOS) results lacked scientific invalidation or an identifiable cause, potentially masking underlying quality control issues. Secondly, validation of bottle sealing processes, including induction and cap sealing, was deemed incomplete, with critical parameters insufficiently established, recorded, or tested, and sealing equipment not formally qualified. This compromises the integrity and stability of drug product containers. Lastly, the plumbing system contained defects, specifically a water storage tank connected to fire prevention lines without adequate backflow prevention, and the presence of "dead legs" in the water system, both creating risks of product contamination and bacterial proliferation.

Verbal remarks also addressed incomplete water system validation, lack of robust sanitization procedures for water piping, and an ineffective systematic approach to root cause analysis in deviation investigations. Management acknowledged these findings and committed to implement corrective actions, providing a written response to the FDA within 15 working days.