PCI Synthesis Announces Another Successful FDA Audit of its Newburyport, MA Facility
December 10, 2008. Newburyport, MA – PCI Synthesis announced today the U.S. Food and Drug Administration (FDA) has completed another successful inspection of its developmental and commercial scale manufacturing facilities in Newburyport, Massachusetts
(EMAILWIRE.COM, December 11, 2008 ) PCI Synthesis announced today that the U.S. Food and Drug Administration (FDA) has completed another successful inspection of its developmental and commercial scale manufacturing facilities in Newburyport, Massachusetts. This is the fourth successful inspection of the company's facilities since 2005 and less than five months after a pre-approval inspection of its Devens facility in which the agency had no 483 observations(www.pcisynthesis.com).
"I'm pleased to report that we have had another successful inspection of our facilities by the FDA. Last year, in response to the constantly changing regulatory environment and the increased regulatory vigilance required by our virtual and emerging pharma customers, we embarked on a comprehensive corporate wide strategic plan to even further improve our existing quality functions. We increased our staff, procured additional resources and modeled our systems after other world class organizations. I'm very proud of everyone within our organization as both the agency and our customers have validated our efforts with these positive audits and very favorable inspections over the last month. Our analytical and quality assurance groups have done a remarkable job working together as a cohesive team and have proven their commitment to our customers by fostering an environment that is committed to continuous improvement," 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. For more information about PCI Synthesis, go to www.pcisynthesis.com.
"I'm pleased to report that we have had another successful inspection of our facilities by the FDA. Last year, in response to the constantly changing regulatory environment and the increased regulatory vigilance required by our virtual and emerging pharma customers, we embarked on a comprehensive corporate wide strategic plan to even further improve our existing quality functions. We increased our staff, procured additional resources and modeled our systems after other world class organizations. I'm very proud of everyone within our organization as both the agency and our customers have validated our efforts with these positive audits and very favorable inspections over the last month. Our analytical and quality assurance groups have done a remarkable job working together as a cohesive team and have proven their commitment to our customers by fostering an environment that is committed to continuous improvement," 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. For more information about PCI Synthesis, go to www.pcisynthesis.com.
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