USFDA issues Form 483 with 8 observations to Biocon: Malaysia

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USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on January 13, 2024 by The Health Master

Biopharmaceutical firm Biocon Biologics said that it was issued 8 observations by the US Food and Drug Administration (USFDA) at its Insulins Manufacturing Facility in Malaysia.

The USFDA issued a Form 483 — a form listing violations — after inspections between July 10 and July 20 this year.​

The USFDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.

The US drug regulator issued 6 observations for Drug Substance, Drug Product units and Quality Control laboratories and 2 observations for the Delivery Devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics.

These observations mostly concern improving operating practices and strengthening training initiatives.

No systemic non-compliance or breaches of data integrity were found during the inspections, Biocon said in its statement with the stock exchanges.

Biocon is confident of addressing these observations expeditiously, and remains committed to global standards of quality and compliance, its statement said.

“We will submit a Corrective and Preventive Action (CAPA) plan to the USFDA in a timely manner and are confident of addressing these observations expeditiously.

Biocon Biologics remains committed to global standards of Quality and Compliance,” Biocon spokesperson’s statement read.

At the close of market hours on July 21, Biocon was quoting at Rs 264, down Rs 2.50 or 0.94 percent on the BSE.

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