Aurobindo Pharma receives warning letter from India's SEC following more FDA question marks
Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.
According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.
The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.
The Business Standard report notes that the warning letter observes that the company had disclosed very limited and restricted information. The letter also did not consider the observations from the FDA as serious. SEBI in turn has advised the company to ensure compliance with all applicable provisions of SEBI’s regulations and to place this warning letter before its board of directors.
According to an article from The Economic Times, Aurobindo Pharma acknowledged that it did receive the letter from SEBI but offered no other details. In turn, Aurobindo did not respond to an inquiry from Endpoints News.
Initially reported in January, Aurobindo’s Unit 1 was slapped with a 483 following an August 2021 inspection. According to the 483, seven observations were made, including improper maintenance of equipment, systems for evaluating critical materials being inadequate and manufacturing components not being tested and released before use, among other infractions.
However, this inspection at Unit 1 is not even the most recent time the FDA has written up the company. Earlier this month, the FDA saw several observations at Aurobindo’s Unit VII formulation plant in the village of Polepally, India during an inspection in early May.
There, investigators found an unexplained discrepancy and a failure of a batch of its components to meet any of its specifications, a lack of written procedures for production and process controls as well as batch production and control records not including complete information relating to the production and control of each batch, among other observations.
Overall, the company has received a total of 15 FDA 483s since 2016, with Unit 1 being cited twice.
The company has seen its stock on the Indian exchange drop 29% over the past six months.