Mumbai, July 6 -- The inspection was carried out from 29 June to 3 July 2026 and marked the first US FDA review of the facility since its acquisition by the company last year. Rubicon Research said that during the 12 months following the acquisition, it completed the integration of the facility, implemented its quality management systems, and fulfilled regulatory filing requirements that led to the inspection.

At the conclusion of the inspection, the US FDA issued a Form 483 with two observations. The company clarified that the observations are procedural in nature and do not relate to data integrity. It added that it is confident of working closely with the regulator to address the observations and complete the evaluation process in a t...