Inspection Flags Sanitation, Quality Control Lapses at Biocon
FDA has cited Biocon Biologics Limited for a series of manufacturing and quality control deficiencies following an inspection of the company’s drug substance manufacturing facility in Bengaluru, India, according to a just-posted FDA Form 483. The inspection, conducted between 8/26 to 9/3/2025, identified multiple concerns spanning facility sanitation, equipment maintenance, laboratory controls and quality system oversight.
FDA investigators documented standing liquid puddles in classified Grade C and D manufacturing areas, the presence of soiled cleaning equipment in controlled environments, and leaks from manufacturing equipment that had not been formally investigated or documented, according to the Form 483. Among the most serious findings were failures to establish or follow written procedures for facility sanitation and equipment cleaning. Inspectors reported visible rust and removable brown material on laminar airflow (LAF) units used during drug substance manufacturing, as well as stains on air filtration components. In some cases, dynamic airflow visualization studies did not include equipment and materials routinely used during production, raising questions about contamination control.
The agency also cited deficiencies in how the company investigated microbiological out-of-specification and out-of-alert-limit results. Several investigations linked recurring microbial contamination— including organisms such as Ralstonia and Delftia species — to potential shortcomings in sanitization procedures and equipment integrity. FDA inspectors noted that the company failed to conduct comprehensive retrospective reviews of similar prior events or to perform holistic assessments of system integrity, cleaning validation and biofilm control strategies.
Quality system weaknesses extended to equipment repairs and labeling practices. In one instance, a system that failed repeated leak tests was repaired using an engineering-grade material without a documented impact assessment, risk analysis or verification of effectiveness. Inspectors also observed crumpled sterilization labels placed on containers in controlled areas without documentation explaining the condition of the labels.
Additionally, laboratory control systems were found to be lacking. FDA reported missing final disposition records for expired environmental monitoring media plates, unresolved analytical balance errors and software error codes on laboratory equipment that had not been adequately assessed or followed up with vendors or engineering teams.