The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483. The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s ...

The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.   The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Qua...

The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.   “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said Jeff Shuren, director at the FDA’s Center for Devices and Radiologi...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...

Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...

The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Big Drugmakers Push Back Against Quality Data Requirements in TGA Provisional Approval Plan A who’s who of leading drugmakers have raised concerns about the proposed data requirements for Australia's provisional approval pathway. The concerns center on the potential for the need to provide months of stability data and achieve good manufacturing practice (GMP) clearance...

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...