Latest News | USFDA Classifies Inspection of Zydus Unit as 'Official Action Indicated'

New Delhi, Jul 18 (PTI) Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions.

The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024.

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The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added.

According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection.

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"The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said.

Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.

(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)