Sun Pharmaceutical has hit pause on releasing U.S.-bound drugs produced at its Mohali manufacturing operations in India.
In a notice filed with the National Stock Exchange (PDF) in India, the company said the U.S. FDA changed the classification of an August 2022 inspection from “Official Action Indicated” to “Consent Decree Correspondence/Non-Compliance Letter.”
The FDA told Sun to “take certain corrective actions at the Mohali facility before releasing further final product batches into the U.S.," according to Sun's filing.
Additionally, the agency told the company to hire an independent CGMP expert to perform batch certifications for drugs produced at the site.
“The company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until U.S. FDA mandated measures are implemented,” Sun said in the filing. “U.S. shipments from Mohali will resume once these measures are in place.”
After the August inspection, the FDA hit Sun with a Form 483 citing six observations. Those observations mostly focused on inadequate testing and record-keeping at the site.
Then, in early December, the FDA hit Sun Pharma with an import alert focusing on its drug manufacturing facilities in Gujarat, India. The FDA excluded 14 products from the import alert subject to certain conditions, though Sun Pharma didn’t disclose the names or type of products.
For that plant, the import warning came in the wake of an inspection conducted between April 26 and May 9 last year.