Rubicon Research announced that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection (triggered by a product filing) of the company's manufacturing facility located at Plot No. K30/4 & 30/5, Additional M.I.D.C., Anand Nagar, Ambernath, Maharashtra, India from Wednesday, 21 October 2026 to Thursday, 29 October 2026. This was a comprehensive GMP inspection in addition to the product application under review.
Upon conclusion, a Form 483 containing 3 observations with respect to system improvement and 2 observations with respect to product application under review were issued, all 5 of which are procedural in nature and do not relate to data integrity. The company is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner.
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