Last Updated on September 23, 2025 by The Health Master
Form 483
The US Food and Drug Administration (USFDA) completed an audit of Biocon’s biosimilars arm, Biocon Biologics, at its manufacturing site in Bengaluru, Karnataka, and issued a Form 483 with 5 observations.
The inspection occurred on September 3, 2025, and resulted in a Form 483 with 5 observations.
But what does this mean for the company? And why is it relevant to the general pharmaceutical landscape?
USFDA Inspects Biocon in Bengaluru
Biocon Biologics’ Bengaluru campus recently underwent an extensive USFDA inspection of all drug substance manufacturing units, analytical QC laboratories, microbiology labs, and warehouses.
According to the report, Biocon addressed that the five observations are procedural in nature and do not raise concerns about data integrity issues, noncompliance on a systemic level, or failure to comply with quality assessments.
If the observations are procedural and not product-related, this is a good sign that they are easily remedied based on SOPs or standard operating procedures, as opposed to major flaws within the drug substance manufacturing process.
What Is a USFDA Form 483?
The USFDA conducts drug manufacturing audits to determine whether a facility complies with Current Good Manufacturing Practice (CGMP) regulations, basically a mandated physical and health check of the medicine-making environment.
If the USFDA inspectors find conditions or practices that may be violating the cGMP standards, they’re obligated to call them out.
Form 483 is a notification of sorts.
It constitutes a list of violations or deviations from compliance regulations, but it’s not a death sentence and not legally binding.
It’s simply a notification by the USFDA to the management of the facility that they have observed certain items that need to be addressed, and it’s expected that a timely and thorough explanation will be provided in response to the findings.
What’s Next for Biocon?
Biocon must submit a Corrective and Preventive Action (CAPA) plan to the USFDA within a specified time frame addressing the five observations.
A response to Form 483s via a CAPA plan is required to maintain compliance and show remediative efforts.
After this notice, Biocon states that such observations will not affect its supply of commercial products, which is good news for investors and patients alike.
Why This Matters in Pharmaceuticals
USFDA inspections are commonplace in ensuring safety and efficacy across drugs.
Reports like these keep companies accountable for their product standards and maintain quality assurance.
Such inspections highlight how much effort, beyond the drugs themselves, goes into compliance with international regulations.
Q: What is a biosimilar?
A biosimilar is a biological product that is highly similar to an already licensed biological product (also known as the reference biological product). There are no clinically meaningful differences between the biosimilar and reference biological product in safety, purity, and potency.
Q: What is a drug substance?
The drug substance is also referred to as the active pharmaceutical ingredient (API) for any drug that creates the intended therapeutic effect; essentially, it is the raw material by which the drug product is created.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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