The FDA has issued its final inspection report for an Aurobindo plant in India after a September inspection and a subsequent Form 483. The agency classified the plant as needing "voluntary" action, prompting investors to bid shares up.
Aurobindo disclosed the FDA's classification of the site as "Voluntary Action Indicated" in a filing with the National Stock Exchange and the BSE.
FDA inspectors visited the site, located in the Indian state of Andhra Pradesh, between September 13 and September 19.
Following the inspection, the U.S. regulatory agency issued a Form 483 that cited one observation. The site is a formulation manufacturing facility.
At the time of the 483, Aurobindo said the FDA's lone concern with the plant was "procedural in nature."
"We will respond to the US FDA within the stipulated timelines and work closely with the U.S. FDA to close the observation at the earliest," the company said in September.
News of the VAI classification sent Aurobindo shares soaring to a 52-week high of Rs 1,081.95 ($13) per share, according to reports.