Biocon gets USFDA observations for Malaysian facility

Biopharma major Biocon on Wednesday said it had received six observations from the US regulator US Food and Drug Administration (USFDA) during an inspection of its Malaysian facility. The US regulator had issued a Form 483 with six observations, said the company in a regulatory filing. “The USFDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with six observations,” Bengaluru-based Biocon said in the filing. The Form 483, or “Inspectional Observations”, is a form used by FDA to document and communicate concerns discovered during the inspections. A recipient of Form 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.

Biocon did not disclose further details about the observations. “As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” added the company statement. During Wednesday’s trade on the BSE shares of Biocon closed at Rs 581.70 apiece, up 1.63%, as against the previous close.