US FDA designates Cipla’s Goa plant as ‘Official Action Indicated’

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

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

It states that an FDA 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 FDA that the classification of the company’s said facility continues to be as OAI,” Cipla said in a regulatory filing.

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

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

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

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

Edits by EP News Bureau