Latest News | Alkem Laboratories Indore Facility Receives Observation from USFDA

New Delhi, Jul 7 (PTI) Alkem Laboratories Ltd on Thursday said the US health regulator has issued Form 483 with one observation after inspecting its facility at Indore in Madhya Pradesh.

As per USFDA, Form 483 is issued to a firm's management after the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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The US Food and Drug Administration (USFDA) had conducted a Good Manufacturing Practice (GMP) and pre-approval inspection at the company's Indore manufacturing facility from July, 1 2022 to July 7, 2022, Alkem Laboratories said in a regulatory filing.

"At the end of the inspection, the company has received Form 483 with one observation with respect to ANDA (Abbreviated New Drug Application) filed for the products to be manufactured at the said plant. There is no data integrity observation," it added.

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"This GMP and pre-approval inspection is part of the routine business operations and the company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observation," the company said.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)