USFDA designates Cipla’s Goa plant as ‘OAI’

It states that a USFDA inspection revealed significant objectionable conditions or practices, and action must be taken to address the issues.

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USFDA
Picture: Pixabay

Last Updated on November 28, 2022 by The Health Master

New Delhi: Drug major Cipla said the US Food and Drug Administration (USFDA) has classified its Goa plant as ‘Official Action Indicated’ (OAI), impacting product approvals from the facility meant for the US market.

According to the USFDA definition, “Official Action Indicated” (OAI) means “objectionable conditions were found and regulatory administrative sanctions by the FDA are indicated” during inspections.

It states that a USFDA inspection revealed significant objectionable conditions or practices, and action must be taken to address the issues.

“We wish to inform you that the company has received a communication from the USFDA that the classification of the company’s said facility continues to be OAI,” Cipla said in a regulatory filing.

The USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved, it added.

The company has an ongoing de-risking plan in place for new product approvals, the Mumbai-based drug major said.

Cipla will work closely with the USFDA and is committed to addressing these within the stipulated time, it added.

The USFDA inspected the company’s Goa plant in August this year.

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