USFDA issues warning letter to Divis Labs for Vizag unit
NEW DELHI: Drug firm Divis Laboratories today said the US health regulator has issued a warning letter to the company for its Visakhapatnam facility.
The United States Food and Drug Administration (USFDA) has issued warning letter for the company's Unit-II at Visakhapatnam, Divis Laboratories said in a BSE filing.
The company along with external consultants and subject matter experts is working to address the concerns of USFDA 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 USFDA 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 USFDA," it added.
In the import alert issued earlier, the regulator had exempted several products manufactured at 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 March 22, 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.
The United States Food and Drug Administration (USFDA) has issued warning letter for the company's Unit-II at Visakhapatnam, Divis Laboratories said in a BSE filing.
The company along with external consultants and subject matter experts is working to address the concerns of USFDA 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 USFDA 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 USFDA," it added.
In the import alert issued earlier, the regulator had exempted several products manufactured at 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 March 22, 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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