Cipla - Pithampur Facility Form 483 Observations, Expect Official Action Indicated Status: Systematix

Systematix Research Report

The U.S. Food and Drug Administration inspected Cipla Ltd.’s Pithampur, Indore facility from February 06 to 17th Feb, 2023. The company had received eight observations for which we have received the Form 483. We hosted a call with Dr. Gurudatta, a regulatory consultant to share his views on the Form 483. The key takeaways being –

1. An official action indicated status / warning letter is the likely outcome which should impact future approvals from the manufacturing facility. OAI status / warning letter is expected as the observations pertain to lack of compliance on procedures for sterility assurance, inadequate investigation on customer complaints and some observations raises suspicion on data integrity (although not established).

2. gAdvair is potentially a key approval that is pending from this facility. We expect the approval to be delayed by at least a year. However, despite the delay, we would still expect the opportunity to remain meaningful and relevant. There are potentially other respiratory assets also filed from this facility.

3. Site transfer of products may not be an option as the process may take longer than it may take to resolve the compliance issues. We are also not sure if Cipla has an alternative manufacturing facility that has capability to manufacture dry-powder inhaler devices.

4. Remediation activity may take at least one year. One of the key observations in the form 483 pertained to customer complaints on products shipped from the Pithampur facility, and failure to conduct investigation and take timely action on Field alert reports. The quantum of customer complaints is disproportionately high. Resolution of the above observation will define the critical path.

5. An import alert is unlikely as data integrity issues have not been established.

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