PCI Synthesis Announces Another Successful FDA Audit of its Devens, MA Facility

The 3rd successful inspection of the company's facilities since 2005

Posted: June 1, 2008

API Manufacturing and Pharmaceutical Manufacturing

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.

Contact:

CarolAnn Price
Marketing Manager
PCI Synthesis
(617) 875-1632
Carolann.price@pcisynthesis.com

Related posts:

New England CRO/CMO Council to Hold Town Hall Meeting and Discussion
Pharmaceutical Manufacturer, PCI Synthesis deepens connections with signing of a dozen local biotech...
PCI wins top regulatory award –what that mean for you
PCI Synthesis’ sponsorship of NE CRO/CMO council aims to boost region’s life sciences cluster
You’ve Got to Exit Sometime: What Every Business Owner Needs to Know about Selling Their Company

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.