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Gen-Probe’s Tepnel Pharma Service is pleased to announce that its analytical laboratories in Livingston, Scotland, have successfully passed a GMP inspection by the US Food and Drug Administration (FDA) without any “Form 483” citations. This is the second audit by the FDA since Tepnel relocated to its current facilities in 2008, and sits alongside the certification by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP, GLP and GCP compliance at the site.
Carl Hull, CEO of Gen-Probe Incorporated, said, “This accomplishment reflects our long-standing corporate commitment to quality and regulatory compliance.”
Gen-Probe’s Tepnel Pharma Services is a global provider of outsourced services to the drug development industry. Tepnel specializes in providing pharmaceutical testing and research in the areas of batch release and stability testing, clinical trials support including bioanalysis and pharmacogenomics, and immunology.
Tepnel Pharma Services is an established brand of Gen-Probe Incorporated.