Saturday 19 August 2017

Inspections (483s and Warning Letters)

FDA Issues Warning About Implantable Device

July 2, 2012 | No comments

The FDA issued a warning on Friday (June 29, 2012) regarding an implantable medical device manufactured by Covidien Plc subsidiary […]

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Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective

April 24, 2012 | 2 comments

The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some […]

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SEC Charges Medical Device Company Biomet with Foreign Bribery

April 3, 2012 | No comments

The Securities and Exchange Commission announced today that it charged Warsaw, Indiana based medical device company Biomet Inc. with violating the Foreign […]

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Medside Interview – Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?

March 18, 2012 | No comments

If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment […]

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FDA reaches $1 million Settlement with Pennsylvania Medical Device Firm

February 29, 2012 | No comments

The FDA Announced today that it reached a settlement with Globus Medical Inc. for the distribution of unapproved medical devices. The FDA and Globus […]

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New Jersey Company Agrees to Halt Production of Unapproved Dental Devices

February 14, 2012 | No comments

The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical […]

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EC’s Commissioner for Health and Consumer Policy Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

February 10, 2012 | No comments

The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the […]

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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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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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