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September 08, 2015
A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
August 19, 2015
Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
July 23, 2015
FDA warns an Arkansas compounding company that it is in violation of the FDCA.
July 14, 2015
FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
July 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
June 04, 2015
The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.
May 04, 2015
FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
April 10, 2015
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
February 23, 2015
The agency cites Apotex’s Bangalore facility with quality system failures.
December 31, 2014
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.