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# Biocon Gets Insulin Aspart BLA Rejection
- URL: https://www.fdaweb.com/biocon-gets-insulin-aspart-bla-rejection/
- Published: 2023-10-09T12:00:00.000Z
- Updated: 2026-09-14T19:01:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155515

FDA has issued Biocon Biologics a complete response letter on its BLA for insulin aspart. While the letter did not identify any outstanding scientific issues with the product, the company did say it references a requirement for a “satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for insulin aspart, held in August 2022.”

Biocon says it submitted a comprehensive corrective and preventive action (CAPA) plan last month that the agency reportedly found to be adequate. FDA indicated that it would require a re-inspection of the Malaysia facility prior to the BLA’s approval, it adds.

Additionally, Biocon says that in February a report from an independent third-party consultant was submitted that provided evidence of the CAPA plan’s completion and effectiveness. However, a pre-approval reinspection was not scheduled prior to the user fee goal date of 10/6, it says, adding that the company will continue to engage with FDA to seek an “expeditious resolution and approval.”