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# Biocon Complete Response Letter on Insulin Biosimilar
- URL: https://www.fdaweb.com/biocon-complete-response-letter-on-insulin-biosimilar/
- Published: 2023-01-12T12:00:00.000Z
- Updated: 2026-09-14T18:11:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153533

FDA has issued Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart. The letter cites additional data needing to be submitted and confirmation that a corrective and preventive action plan has been implemented to address findings from a preapproval inspection at two Bangalore, India facilities in 8/22.

Last September, the agency posted the Form FDA-483s from the inspections at these facilities. The FDA-483s show 11 inspection observations each for the two sites, and indicated a need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerized tools to aid risk assessment and investigations, and other procedural and facility upgrades. The FDA-483s are available below:

- [Biocon Biologics](https://www.fda.gov/media/161809/download?ref=fdaweb.com)Bommasandra-Jiganis Link Road, Bengaluru, India
- [Biocon Biologics](https://www.fda.gov/media/161810/download?ref=fdaweb.com)20th KM Hosur Road, Bengaluru, India