USFDA issues 3 observations for Alkem Labs Mandva facility
Mumbai: Through a recent BSE filing, Alkem Labs has informed that the Company has received Form 483 with three observations from the United States Food and Drug Administration (USFDA) at the end of the inspection conducted at the Company’s API manufacturing facility located at Mandva. There is no data integrity observation.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
USFDA inspected the facility from 27th November, 2023 to 01st December, 2023.
"This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," Alkem said.
Alkem Laboratories Ltd is an Indian pharmaceutical company engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals in acute and chronic therapeutic areas, such as anti-infective, pain and analgesics, vitamins/minerals/nutrients, cardiac and Diabetology, Gynecology, Ophthalmology, neuro/central nervous system, dermatology, anti-diabetes, anti-osteoporosis, cardiovascular, and muscle relaxants, which are marketed in Indian and International markets. It operates through the pharmaceutical business segment.
