US shipments from Mohali will resume once these measures are in place. US shipments from Mohali will resume once these measures are in place. US shipments from Mohali will resume once these measures are in place. Pharmaceutical major Sun Pharmaceutical Industries on Sunday said that there will be a temporary pause in the release of final product batches from its Mohali manufacturing unit until it implements the US Food and Drug Administration (FDA) mandated measures.
In its regulatory filing, the company informed that it has received a letter titled “Consent Decree Correspondence/Non-Compliance Letter" from the US FDA.
"US FDA has directed the Company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US," the company said.
"These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility," it added further.
It further said that the company is taking the required corrective steps, but there will be a temporary pause in the release of batches from Mohali until US FDA-mandated measures are implemented.
Therefore, US shipments from Mohali will resume once these measures are in place.
Sun Pharma's Mohali facility came under the scanner of the US regulator in August last year when it carried out an inspection of the plant from August 3 to August 12, 2022. US FDA had classified the inspections as “Official Action Indicated" (OAI).
After the US FDA inspects a manufacturing facility, it puts the facility under question in one of the three categories- No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).
Official Action Indicated means that objectionable conditions were found and regulatory action should be recommended, according to the US FDA official website.