Successful Inspection by FDA of Almac Clinical Services North Carolina Facility
March 5, 2010
Almac Clinical Services is pleased to announce the completion of a successful inspection of its Durham, North Carolina facility by the US Food and Drugs Administration (FDA) on Monday 22nd February.
The FDA performed the one day general inspection of the facility which included packaging, warehousing and distribution operations as well as quality systems – no 483 was issued.
Commenting on the inspection, Paul O’Connor (Vice President, Quality) said:
“We are delighted with the results of this latest inspection. It is testimony to the continued dedication and effort of our employees who ensure that our procedures and processes fully adhere to GMP requirements and the high standards set by the various international regulatory bodies. As one of our core values – “Quality” is central to our business ethos and ultimately the key to our future sustainability and success. We hope this latest announcement is of great reassurance to our clients, who ultimately rely on our commitment to provide a high quality framework to ensure their clinical trials are a success.”
Tel: +44(0)28 3836 2436
Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.
The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters in PA started in July 08 and will be completed in 2010.