Dalton Pharma Services announced that the US Food and Drug Administration (FDA) completed a PAI inspection of its Health-Canada licensed manufacturing facility in Canada, in January 2019. This inspection paves way for Dalton to manufacture commercial API products for US distribution.
The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by US FDA. No FDA 483 inspectional observations were issued. This inspection means that the company has successfully demonstrated these activities are in compliance with the high standards of the Food and Drugs Act and its associated regulations.
“This successful inspection is a critical breakthrough for Dalton as it is the first ever PAI at our facility. The successful FDA inspection with no 483s demonstrates our commitment to meeting all applicable regulatory standards for commercial manufacture, packaging and testing,” Natalie Lazarowych, Director of Quality, said.
“I am proud of my team and their efforts in accomplishing this organizational milestone. Our hardworking, dedicated and exceptional employees are our greatest asset. This successful inspection exemplifies Dalton’s commitment to being a compliant cGMP API manufacturer for all our client`s drug candidates.”, said Peter Pekos, CEO.