Report - Analysis of FDA 483 issued to Cipla Limited

In June 2024, the U.S. FDA issued a 483 to a Cipla site in the Indian state of Goa. This 483 is noteworthy for a few reasons, which prompted this analysis. We believe that a more serious enforcement action like a Warning Letter may soon follow.

It repeats observations seen at the same site two years ago, and similar observations were noted at other Cipla sites recently. So there’s a broader pattern here, as well as a lack of evidence of improvement.

Furthermore, a high percentage of the observations are classified as “Major” by Redica Systems, meaning that there is substantial risk.

Download this report to see the detailed observations and deficiencies and to learn more about Redica Systems’ Site Risk Scoring.

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