Jiangsu Willing Passes FDA InspectionNews
Rochem International is pleased to announce that our strategic manufacturing partner, Jiangsu Willing BioTech Co., Ltd., (Willing) has successfully passed a US FDA inspection in August 2019 with no 483 observations. Rochem’s Regulatory and Compliance department has worked closely with the Willing team since the passing of their pre-approval inspection by the US FDA back in December 2017 to ensure the facility maintained compliance with Good Manufacturing Practices.
The result of a zero observation 483 on the recent US FDA inspection at our Chinese partner, Jiangsu Willing, is a major milestone for our Animal Health business. This excellent result is the culmination of years of work between our two companies and validates the investments made into the new facility by Willing have delivered the expected results that our customers in the Animal Health industry rely on as they prepare to launch their finished products with our APIs from the site.
Robert Johnson, Sr. VP of Animal Health at Rochem International, commented “We are very proud of the staff at Willing for their commitment to quality and to the company chairman, Mr. Ling, for his ongoing commitment and investments in the facility”.