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December 07, 2016
Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.
November 28, 2016
Wockhardt Limited received a warning letter from FDA for CGMP violations.
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
November 18, 2016
CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.
November 03, 2016
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
November 02, 2016
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
October 26, 2016
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
October 13, 2016
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
October 12, 2016
FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.