The USFDA had conducted inspection at Sun Pharmaceutical Industries Limited's Mohali (Punjab) facility from August 3 to August 12, 2022. The USFDA had classified the inspection as "Official Action Indicated" (OAI).

The company has received a letter titled "Consent Decree Correspondence/non-compliance Letter” from the USFDA.

USFDA has directed the company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US. These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility.

The company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until US FDA mandated measures are implemented. US shipments from Mohali will resume once these measures are in place.