USFDA issues Form 483 with 6 observations to Cipla

The company said the Goa plant recently underwent a United States Food and Drug Administration (USFDA) inspection from August 16 to 26, 2022.

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USFDA Form 483
USFDA Form 483

Last Updated on October 6, 2024 by The Health Master

The pharma major, Cipla, has announced that the company has received six observations from the US Food and Drug Administration (USFDA) following the inspection conducted in August 2022 at its Goa plant.

The company said the Goa plant recently underwent a United States Food and Drug Administration (USFDA) inspection from August 16 to 26, 2022.

Earlier, the USFDA inspected the company’s Goa manufacturing facility in September 2019. A warning letter for the same was received by the company in February 2020.

The company further informed that on the conclusion of the inspection, the company has now received 6 observations, with some referencing to the observations made during the September 2019 inspection. There are no data integrity observations.

“The company will work closely with the USFDA and is committed to addressing these within the stipulated time, the company said in a filing with BSE.

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.

Cipla primarily develops medicines to treat respiratory and cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.

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