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# 3 Biocon Biologics FDA-483s Posted
- URL: https://www.fdaweb.com/3-biocon-biologics-fda-483s-posted/
- Published: 2022-09-26T12:00:00.000Z
- Updated: 2026-09-14T18:00:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152816

FDA has released three Form FDA-483s issued to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-insulin, and insulin aspart, and a capacity expansion for biosimilar trastuzumab. “These included multiple drug substance and drug product facilities and other support infrastructure at these sites,” the company says.

The FDA-483s show 11 inspection observations each for the two Bengaluru sites and six observations for Johor. They 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 Sdn](https://www.fda.gov/media/161811/download?ref=fdaweb.com). Johor, Malaysia
- [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