Another FDA inspection ends in 483 for Biocon in Malaysia

Biocon’s insulin production facility in Malaysia has received a US FDA Form 483 with eight observations concerning operational procedures and training programs.

The US Food and Drug Administration (FDA) inspected Indian biopharma giant Biocon’s manufacturing facility in Malaysia between July 10 and July 20. The site produces regular, basal, and rapid insulins, including its biosimilar insulin product, which is a follow-on insulin glargine referencing Sanofi’s Lantus.

The 10-page FDA report details eight observations, ranging  from issues with cleanliness, drug product units, delivery devices, drug substances, quality control laboratories, and a lack of integrity testing. Furthermore, inspectors discovered employees were not being provided with refresher training.

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This is not the first time the FDA has found issues at Biocon’s Malaysia facility. In September 2021, the plant received a Form 483 from the organization with six observations. Specifics of the six observations were not disclosed but the firm remained positive that it can address the identified issues with procedural enhancements and a Corrective and Preventive Action Plan (CAPA).

Additionally, in July 2019 the same plant received a Form 483 with 12 observations. None of the observations related to data integrity. However, several of the observations were repeats from a pre-approval inspection carried out in February 2018. 

The FDA has also rejected Biocon and Mylan’s follow-on biologic insulin glargine product referencing Sanofi’s Lantus. In June 2018, the organization issued a complete response letter (CRL) to both parties and denied authorization of the product.

Just over a year later, the firms reported a second CRL had been received from the agency, but remained confident about the commercial launch of its insulin glargine in the US.

BioProcess Insider contacted Biocon for comment but had not received a response at the time of publishing.