Sun Pharma gets warning letter from USFDA for Halol plant

New Delhi: Drug major Sun Pharma on Friday said it has received a warning letter from the US health regulator for its Halol facility which is already under an import alert. The warning letter summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, the Mumbai-based company said in a regulatory filing.

The US Food and Drug Administration shall make public the contents of the Warning Letter in due course, it added.

On December 8, Sun Pharma had announced that its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market.

The Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.

The US FDA then checks to ensure that the company's corrections are adequate.