FDA Flags Lapses at an Insulin Facility in Malaysia

Biocon is a biotechnology company based in Malaysia, with manufacturing facilities that play a significant role in producing biopharmaceuticals such as insulin. However, the company’s insulin manufacturing facilities have recently faced renewed warnings from the U.S. Food and Drug Administration (FDA), indicating issues with its production processes.

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Repeated FDA Concerns to Biocon

The manufacturing facilities of Biocon in Malaysia have clearly become a focal point of FDA attention. In August 2022, an FDA inspection revealed six observations that had an impact on Biocon’s production plans, particularly regarding the production of Semglee, an insulin biosimilar by Viatris. Prior to this, Biocon had received complete response letters from the FDA in August 2019 and February 2020, serving as warnings.

This year, between July 10 and July 20, the FDA conducted another inspection of Biocon’s manufacturing facilities. Following this inspection, the FDA issued a Form 483 titled “Notice of Inspectional Observations,” listing six observations made during the inspection that may be in violation of the U.S. Food, Drug and Cosmetic Act and related laws and regulations. These observations include storing scissors in the aseptic processing area to open sterile packaging, blocked air filters left untreated, insufficient aseptic mechanical cleaning, and issues with batch testing and record-keeping. One of the observations noted that Biocon failed to provide a written procedure for addressing loss of differential pressure in the aseptic area. There were also indications of inconsistent product quality and inadequate cGMP (Current Good Manufacturing Practice) training for employees.

Biocon Submits CAPA Plan to Address Warning

In response to this warning, Biocon has stated that they have submitted Corrective and Preventive Action Plan (CAPA) to the FDA to address the observations raised during last year’s inspection. Biocon has mentioned that the FDA has accepted this CAPA plan. A spokesperson for Biocon noted that they cannot comment on behalf of the FDA in terms of timing. Additionally, the company stated that this inspection is unrelated to its Insulin Aspart product.

The repeated FDA warnings against Biocon’s Malaysian manufacturing facilities highlight issues with the company’s production processes and could impact its production and product approvals. While the company’s products have received approvals in multiple global markets, these ongoing issues could pose challenges to its reputation and operations. Past warnings and the current observations indicate the need for further improvements in the operational procedures of the manufacturing facilities to ensure the quality and safety of the biopharmaceutical products produced. This incident serves as a reminder of the complexity of biopharmaceutical production and the importance of regulatory compliance.

Author

Sinead Huang