The United States Food and Drug Administration (US FDA) has issued a warning letter to drug maker Sun Pharmaceuticals specifying violations of norms in its manufacturing facility at Halol in the Panchmahal district of Gujarat.

In its letter, the US drug regulator noted that the pharma company failed to establish and follow appropriate written procedures. The procedures have been designed to prevent microbiological contamination of drug products.

In its warning letter issued on December 15, 2022, US FDA noted that the company failed to perform operations within specifically defined areas of adequate size, and failed to use equipment in the manufacturing process, packing, and holding of appropriate drug products.

Among other violations, the pharma major failed to thoroughly investigate any discrepancy or failure of a batch and failed to clean, maintain, sanitise, sterilise equipment and utensils at appropriate intervals.

The company's Halol unit was placed under import alert on December 7, 2022.

It remains under the Official Action Initiated (OAI) status as 10 (non-compliance) observations were marked in the regulatory inspection report. The US drug regulator inspected the facility between April 26, 2022, and May 9, 2022, and issued the observations.

An import alert means that all future shipments of products manufactured at the particular facility are subject to entry refusal in the US market until the facility becomes compliant with the FDA's current Good Manufacturing Practices.