US FDA issues Establishment Inspection Report for Lexington unit: Piramal Pharma
1 min read . Updated: 16 Feb 2023, 03:06 PM IST
PremiumPiramal Pharma reported a net loss of ₹90 crore on a consolidated basis for the quarter ended December 2022
Piramal Pharma on Tuesday said that US Food and Drug Administration (FDA)has issued an Establishment Inspection Report (EIR) for its manufacturing facility at Lexington in Kentucky, USA. The company said that US FDA had conducted an inspection at the facility from December 19 till January 13.
At the conclusion of the inspection, Piramal Pharma said the US FDA issued a Form-483, with two observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity.
A pre-approval inspection (PAI) is performed to contribute to the FDA's assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
Form-483 is given to a company's management following an inspection if the investigator found any situations that, in its opinion, might be considered violations of the Food, Drug, and Cosmetic Act and associated Acts.
Piramal Pharma reported a net loss of ₹90 crore on a consolidated basis for the quarter ended December 2022.
The Mumbai-based company had reported a net profit of ₹163 crore in the October-December quarter of last fiscal.
Revenue from operations stood at ₹1,716 crore for the third quarter, while the same was at ₹1,539 crore in the year-ago period.
"In furtherance to the aforementioned intimation, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the said manufacturing facility and the inspection has now been successfully closed by the US FDA," said Piramal Pharma in its filing.
The company shares were 5.13 per cent up at 91.20 on BSE.