Indoco Remedies Goa Plant Gets USFDA Warning Letter
Indoco Remedies received a warning letter from the USFDA for its Goa manufacturing plant after failing to meet compliance standards. The company is working to resolve the issues.
New Delhi, Dec 17 (PTI) Drug firm Indoco Remedies on Tuesday said the US health regulator has issued a warning letter to its Goa-based manufacturing plant.
The plant had earlier received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for Plant II & Plant III facility located at Verna, Goa.
"Subsequently, the facility has received a warning letter from the USFDA on December 17, 2024. This facility was inspected from July 16, 2024 to July 26, 2024," Indoco Remedies said in a regulatory filing.
The company remains committed to working closely with the US health regulator and continues to enhance its compliance on an ongoing basis, it added.
"We will work with the USFDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across our facilities," the drug firm said.
The company continues to supply products from the plant to the US market, it added.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
Shares of Indoco Remedies on Tuesday ended 1 per cent up at Rs 344 apiece on BSE.
The plant had earlier received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for Plant II & Plant III facility located at Verna, Goa.
"Subsequently, the facility has received a warning letter from the USFDA on December 17, 2024. This facility was inspected from July 16, 2024 to July 26, 2024," Indoco Remedies said in a regulatory filing.
The company remains committed to working closely with the US health regulator and continues to enhance its compliance on an ongoing basis, it added.
"We will work with the USFDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across our facilities," the drug firm said.
The company continues to supply products from the plant to the US market, it added.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
Shares of Indoco Remedies on Tuesday ended 1 per cent up at Rs 344 apiece on BSE.
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