Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia.
Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food Drug and Cosmetic Act or related acts.
A brief statement on Biocon’s website said, "The US FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner." The drug maker did not elaborate on the nature of the FDA’s observations.
According to Biocon’s website, the Malaysia facility that was the subject of the form will manufacture the company’s insulin products. Biocon first received its certificate of good manufacturing practice compliance for the site from the competent authority of Ireland in April 2017.
However, Cyndrella Carvalho, an analyst with Dolat Capital, told Bloomberg that any deficiencies at the plant could delay FDA approval of the facility, but that the observations made by the agency are unlikely to be serious in nature, as the plant does not yet manufacture any products.
The news of the setback for Biocon comes less than a month after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Biocon’s insulin glargine follow-on (which is classified as a biosimilar in the European Union), referencing Lantus.
This is not the first Form 483 for Biocon; in 2017, the company received a form for issues related to its Bangalore plant, where the company manufactures its biosimilar monoclonal antibodies, pursuant to an inspection carried out between March 27 and April 7. That document noted 8 observations, including issues with the company’s quality assurance unit.