Aurobindo Pharma's Unit XI receives ‘Form 483' with 3 observations from USFDA; stock slips ~3%

3 Aug 2022 , 10:35 AM

Aurobindo Pharma Limited informed that the United States Food and Drug Administration (US FDA) inspected the Company’s Unit XI, an API non-antibiotic manufacturing facility situated at Pydibhimavaram, Srikakulam District, Andhra Pradesh, between the period July 25 to August 2, 2022.

On May 17, 2019, the said Unit was classified as OAI, and USFDA issued a warning letter to the company on June 20, 2019.

The Company has replied to the warning letter and made the corrections mentioned in the letter. The facility received inspection from USFDA authorities between July 25 to August 2, 2022.

Upon completion of the inspection, USFDA  issued a ‘Form 483’ with 3 observations to Aurobindo Pharma. However, none of those observations are related to data integrity.

The company further stated that it will respond to the authority within the stipulated timeline and work closely with USFDA to address the observations at the earliest.

Post this development, the company’s counter slipped 2.84% at Rs558.55 from its previous closing of Rs574.85 on the BSE. The scrip opened at Rs570.60 and touched intraday high and low of Rs573.10 and Rs558.10 respectively.