US FDA issues warning letter to Divis Labs for Vishakhapatnam unit

Divis Labs says the firm is working with external consultants, experts to address the US FDA concerns and is making all efforts to meet the compliance requirements

Divis Laboratories , however, did not provide details of the US FDA  warning letter. Photo: Mint
Divis Laboratories , however, did not provide details of the US FDA warning letter. Photo: Mint

New Delhi: Drug firm Divis Laboratories on Saturday said the US health regulator has issued a warning letter to the company for its Vishakhapatnam facility.

The United States Food and Drug Administration (US FDA) has issued warning letter for the company’s Unit-II at Vishakhapatnam, Divis Laboratories said in a BSE filing.

The company along with external consultants and subject matter experts is working to address the concerns of US FDA and is making all efforts to fully meet the compliance requirements, it added.

The company, however, did not provide details of the warning letter.

Divis Laboratories has responded to US FDA inspection observations with an appropriate remediation process to overcome the deficiencies observed, the company said.

“As part of our commitments, we have also provided periodic updates to the US FDA,” it added.

In the import alert issued earlier, the regulator had exempted several products manufactured at the unit II in Visakhapatnam, Divis Laboratories said.

The regulator had earlier exempted 10 products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert. “We will continue to supply these active ingredients to meet its obligations to our customers”, it added.

The company will respond to this warning letter with a detailed plan within the stipulated time, Divis Laboratories said.

Earlier on 22 March, Divis Laboratories had said in a regulatory filing that the regulator had issued import alert for products made at Visakhapatnam unit citing violation of manufacturing norms and refusal of inspection.

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