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FDA Form 483 Details Biocon’s Malaysia Plant Issues

Posted 13 March 2018 | By Zachary Brennan 

FDA Form 483 Details Biocon’s Malaysia Plant Issues

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 sent last month to Biocon’s Malaysia-based plant, which the company said manufactures its EU-approved insulin glargine biosimilar.

The 483 includes six observations for the $275 million plant, which are focused on procedures to prevent microbial contamination, unexplained discrepancies for drug products, and issues with not following written production and process control procedures.

“Your Quality Unit initiated more than 1,040 deviations from 2015 to 2018, but has failed to extend the investigations of deviations and OOS [out of specification] discrepancies to other batches and products that were manufactured under similar conditions,” the Form 483 said.

In terms of process controls, FDA inspectors said the Johor, Malaysia-based plant from 2016 to 2017 “had over 748 deviations with an average of 17% overdue past the target date and an average of 34% of recurring deviations.”

The Form 483 follows Biocon’s announcement that the EU had signed off on the plant’s compliance and that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation to approve its biosimilar insulin glargine, known as Semglee.

Back in September, Biocon said it received a certificate of GMP compliance from Ireland’s HPRA as the representative EU inspection authority.

Biocon also said in a statement filed with the Bombay Stock Exchange last month on the Form 483: “As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner.”

Form 483

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