Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has issued 10 observations after the inspection of its Gundlamachnoor facility in Sangareddy District Telangana.
The US drug regulator inspected the company’s unit - IX, an intermediate facility situated at Gundlamachnoor Village, from November 10 to November 12.
The unit had been classified as Official Action Indicated (OAI) on May 17, 2019, and the company responded to the agency and carried out the required corrective actions.
The USFDA authorities have re-inspected the facility and at the end of the inspection, the pharma company has been issued a ‘Form 483’ with 10 observations.
According to the company, these observations are procedural in nature and not related to data integrity.
The company said it will respond to the USFDA, within the stipulated timeline and would work closely with the agency to address the observations at the earliest.
It said that it will keep the stock exchanges further informed if there is any material information relating to the above in the future.
An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.
Last week, Aurobindo Pharma announced that it received an Establishment Inspection Report (EIR) from the USFDA for its manufacturing facility at Pydibhimavaram in Andhra Pradesh.
The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the USFDA in February 2019 and issued a warning letter in June 2019. This unit was further inspected by USFDA in July this year and was issued a Form 483 with 3 observations.
Shares of Aurobindo Pharma ended 1.2 percent lower at Rs 463.20.
