A report was received from the FDA in March 2007 advising that Randox Laboratories Limited is deemed to be an acceptable supplier of medical devices to the USA
Following on from the recent announcement of a fifth Queen's Award for Enterprise 2007, Randox Laboratories confirms the successful conclusion of an FDA Inspection that took place at the manufacturing facilities in June 2006.
Randox Laboratories manufactures a range of in vitro diagnostic medical devices.
In order to market and sell these in the United States the devices must first be cleared by the US Regulatory Authority, the Food and Drug Administration (FDA).
In addition to reviewing the safety and effectiveness of medical devices the FDA extends its regulatory control to the manufacturing establishment, requiring compliance with the Quality System Regulation as set out in the Code of Federal Regulations Title 21 Part 820.
To ensure that this is the case the FDA inspect all manufacturing establishments producing medical devices that are sold and marketed in the US.
In April 2006 Randox Laboratories was advised by the FDA that an initial FDA inspection would take place at the manufacturing facility from the 19 to 29 June 2006 inclusive.
It should be noted that an initial inspection lasting ten days is unusually long and allowed the Inspector considerable time to review processes, documents and records.
The inspection was conducted as outlined in the FDA's Quality System Inspection Technique (QSIT).
Four main areas are reviewed during this type of inspection, including management responsibility, design and development control, corrective and preventive action (Capa) and process control.
The inspection confirms that systems have been established, documented and implemented in these four key areas and that the systems are compliant with the FDA requirements.
Pauline Armstrong, QA manager at Randox said, "The fact that the inspection was closed successfully is a tribute to the excellent team spirit that exists at Randox and a reflection of the quality systems that are in place.
"This should give confidence not only to Randox but also to our customers, confirming the quality of the products as the Company moves forward to fulfil our mission statement of revolutionising healthcare through continuously improving diagnostic solutions".
