PCI Synthesis announced today that the U.S. Food and Drug Administration (FDA) has completed an inspection of its kilo scale API Development and manufacturing facilities in Devens, Massachusetts. This is the 3rd successful inspection of the company’s facilities since 2005.
I’m pleased to report that we have had another successful inspection of our facilities by the agency. It’s rewarding to once again receive validation as a result of our strict adherence to our robust quality system. I’m very proud of everyone within our organization. Our process development, manufacturing, analytical and quality assurance groups have done a remarkable job working together as a cohesive team. They’ve proven their commitment to our customers through their diligence and dedication to our quality program,
said Edward Price, President of PCI Synthesis.
PCI Synthesis, headquartered in Newburyport, Massachusetts with Research and Development and small scale manufacturing in Devens, Massachusetts, is a chemical manufacturer serving the pharmaceutical, biotech, biopharmaceutical, fine chemical & medical device industries to produce custom NCE’s, generic API’s & other fine chemical products. PCI Synthesis offers solutions to develop a final API, including process research, process development, analytical development, process validation, regulatory support & FDA filing. PCI operates two FDA inspected cGMP sites in the Boston area.