“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.
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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.
