Yungshin’s Sterile Injection Plant Passed the Inspection of FDA of the U.S. without Deficiency

Upholding the faith in the endless pursuit of quality, Yungshin continues to forge ahead toward global presence. Starting from the 1st of this month, FDA of the U.S. carried out the six-day pre-approval inspection (PAI) for ANDA of sterile injections, including production management, raw material management, facilities and equipment, packaging labeling, quality control, regulatory research and development, and quality management systems, and identified no deficiency. FDA of the U.S. indicated that it would recommend FDA CDER to approve Yungshin’s application for ANDA. The inspection results will benefit the export of oral drugs and sterile injections to the U.S., bringing more profits to Yungshin in the future.