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# FDA Observations from 3 Biocon Biologics Inspections
- URL: https://www.fdaweb.com/fda-observations-from-3-biocon-biologics-inspections/
- Published: 2022-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:58:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152644

FDA has issued a form FDA-483 to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. In a stock exchange [notice](https://www.biocon.com/usfda-consolidated-biocon-biologics-notification/?ref=fdaweb.com), 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 notice says.

Biocon reports there were 11 inspection observations each for the two Bengaluru sites and six observations for Johor. It says the observations related primarily to 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.

“We will submit corrective and preventive action plans to FDA in the stipulated time frame,” Biocon says.