Inspectors from the US Food and Drug Administration (FDA) visited the facility in September 2019. Weeks later it emerged that the inspectors had made seven observations, triggering a double-digit decline in Aurobindo’s share price.
The Indian generic manufacturer provided an update on the situation this week. The US FDA has classified the facility as Official Action Indicated (OAI), meaning the agency found “objectionable conditions” and regulatory action is recommended.
Aurobindo describes the facility as “an ultra-modern unit based on the suite manufacturing concept delivering huge capacity,” adding that it manufactures “non penicillins, non cephalosporins [and antiretrovirals].”
Exactly what the US FDA found is unclear. In its latest statement, Aurobindo said it does not believe the OAI classification will “have any material impact on the existing revenues or the supplies to our US business at this juncture,” but otherwise said little about the nature of the problem.
Aurobindo was somewhat more forthcoming when reports of the US FDA inspection emerged last year. At that time, Aurobindo revealed its belief that none of the seven observations were related to data integrity.
Data integrity is a long-standing issue for Indian drugmakers, many of which have been the subject of regulatory actions related to the failing. Aurobindo added to the list of Indian facilities chastised by the US FDA for data integrity failings last year when its multi-product oral dosage form facility was the subject of a Form 483.
The facility involved in the latest regulatory action against Aurobindo looks to be free from the data integrity failings that blighted the oral dosage form plant. However, whatever problems the facility faces have resisted quick fixes.
In October, Aurobindo said it would respond to the US FDA’s observations within the stipulated time.
Aurobindo’s inability to resolve the problems before they led to an OAI continues the company’s bad run with the US FDA. Last year, the US FDA classified three Aurobindo facilities as OAI. No other company received more than two OAI classifications related to drug quality assurance last year.