CPC Scientific has announced that the CPC Good Manufacturing Practice (GMP) facility in Hangzhou, China has successfully passed its fourth U.S. Food and Drug Administration (FDA) inspection. No Form 483 observations were issued.
Passing this inspection is an important milestone for CPC Scientific and its quality program. This official endorsement ensures potential GMP customers that peptides manufactured by CPC Scientific have passed stringent requirements and meet or exceed global regulatory requirements. As the world's best-in-class provider of GMP peptides, CPC is fully compliant with current FDA cGMP standards.
"I am very pleased with the outcome of this inspection," said Dr. Shawn Lee, President and CEO of CPC Scientific. "CPC has established a rigorous quality and EHS system in compliance with regulatory requirements in many regions including Europe,China, Japan, ICH and WHO. Now we can proudly add this fourth successful U.S. FDA inspection to our growing list."
"This inspection result demonstrates CPC's commitment to regulatory compliance and high standards of quality. It also speaks to our ability to design and build our new state of the art GMP facility expansion to serve future global peptide markets," added Irvine Skeoch, CPC Scientific's Chief Operating Officer.