BioScreen Successfully Completes Inspection at Torrance Lab

BioScreen Testing Services has successfully completed an FDA cGMP inspection of its Torrance lab operations. The inspection supports three ANDA and one NDA submission for the analytical and microbiological portions of the applications. The inspection focused on the company’s Quality Management System and compliance with GMP and addressed the elements of an FDA pre-approval investigation associated with the analytical data specific to each compound. The FDA has notified the company of its intent to recommend approval of BioScreen’s data in support of the drug applications.