Wednesday 24 January 2018

Public Awareness

Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g)

January 31, 2012 | No comments

The FDA released a voluntary recall notice from Vitaflo USA. Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 […]

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Department of Justice Files Consent Decree of Permanent Injunction Against Ranbaxy

January 25, 2012 | No comments

An Indian generic drug maker faces liquidated damages and a permanent injunction under a DOJ consent decree filed today. Ranaxby, is accused […]

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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling

January 20, 2012 | 2 comments

Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA […]

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EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination

January 20, 2012 | No comments

New changes are emerging from the French scandal involving breast implants. The European Commission (EC) will investigate whether or not […]

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Importance of MDR Reporting; J&J Delayed Reporting Insulin Pump Problems

January 11, 2012 | No comments

The Associated Press is reporting that the FDA has warned Johnson & Johnson that it could face fines and other sanctions […]

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Joint FDA-EMA Inspection Program Launches; Lessons for PIP Scandal

January 10, 2012 | 1 comment

Beginning this month the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing facility […]

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Recall:FDA warns about painkiller mix-up in Excedrin, Bufferin

January 9, 2012 | No comments

The Associated Press reported a warning from the FDA about a potential mix-up between powerful prescription pain drugs and common […]

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FDA issues Warning Letters for Misleading Advertising of Lap-Band

December 13, 2011 | No comments

The FDA issued warning letters for misleading Lap-Band advertising which the Agency states lacks information on the risks of gastric […]

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Personal Health Information (PHI) in Corrective and Preventive Action (CAPA)

October 27, 2011 | No comments

Corrective and Preventive Action (CAPA) is a component all medical device facilities, whether importer, distributor, or manufacturer, must comply with. […]

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Medical Device Pre-Market Programs: An Overview of FDA Actions

October 20, 2011 | No comments

Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized the need to re-evaluate and modernize […]

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