Biologics

Biocon Biologics Gets 10-item FDA-483

FDA has posted a Form FDA-483 issued to Biocon Biologics at the end of a July inspection of the firm’s Bengaluru, India manufacturing facility. The document cites 10 observations:

Procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic process.
Procedures designed to prevent microbiological contamination are not followed.
Laboratory test procedures and controls are not established and followed.
Computerized systems lack controls and review of electronic data to prevent omissions in data.
Investigations of an unexplained discrepancy or a failure to meet a specification were not thorough and did not extend to other batches that may have been associated with the discrepancy or failure.
Equipment used in the manufacture, processing, packing or holding of drug products is not maintained in a manner to prevent malfunctions.
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Aseptic processing areas are deficient regarding the system for disinfecting the equipment to produce aseptic conditions.
There are no 'written procedures for production and process controls designed to ensure that the drug products have the quality, and purity they purport or are represented to possess.
Labeling of GMP materials is not adequate to identify the material.

The firm appears to be getting increased scrutiny from agency reviewers and investigators. Last year, FDA issued Biocon Biologics a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentech’s Avastin), citing the need to resolve inspection observations made during a facility inspection in 8/2022. Also last year, a similar complete response letter was issued on its BLA for a biosimilar version of insulin aspart (see earlier story).

In 2022, FDA released three Form FDA-483s issued to firm following on-site August 2022 inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. 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 here:

Biocon Sdn. Johor, Malaysia
Biocon Biologics Bommasandra-Jiganis Link Road, Bengaluru, India
Biocon Biologics 20th KM Hosur Road, Bengaluru, India

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