Mumbai-based pharmaceutical company Rubicon Research Ltd on Friday (October 9) said the United States Food and Drug Administration (US FDA) issued one observation in Form 483 after an unannounced inspection of its manufacturing facility in Satara, Maharashtra, conducted from October 5 to October 9, 2026.
The company said the observation is procedural in nature and does not relate to data integrity. It added that it is confident of working closely with the regulator to conclude the evaluation in a timely manner.
Rubicon Research said a successful outcome would mark the first successful unannounced US FDA inspection of the Satara facility. The site’s previous US FDA inspection took place in January 2023, with prior intimation provided to the company.
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The company said the Satara inspection would be its third successful unannounced US FDA inspection in the financial year 2026-27, following inspections of its Toronto research and development facility in Canada in April 2026 and its Pithampur manufacturing facility in India in July 2026.
Separately, Rubicon Research said its recently acquired manufacturing facility in East Brunswick, New Jersey, in the United States, was inspected by the US FDA in May 2026, shortly before the company acquired the facility in July 2026.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the US FDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
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Post Form 483 is issued, the company is given 15 days time to submit its response to the USFDA explaining what steps will the company take to resolve the observations made by USFDA.
Shares of Rubicon Research Ltd ended at ₹1,551.80, up by ₹18.10, or 1.18%, on the BSE.