FDA says Sun Pharma addressed issues at facility in India
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Issues observed at Sun Pharma’s Halol facility in Gujarat, India, detailed in an FDA warning letter in December 2015, have been addressed, and the inspection is now closed, according to the company.
Sun Pharma received an FDA establishment inspection report regarding a February inspection that stated all issues have been addressed.
“This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and ... [current good manufacturing practice] compliance at all our manufacturing facilities globally,” Dilip Shanghvi, Sun Pharma managing director, said in the release.