Inspections (483s and Warning Letters)
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 …
Read more »
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 …
Read more »
Medside Interview – Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?
March 18, 2012 | No comments
Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US? [ 43:02 ] Play Now | Play in Popup | Download (47)If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
Top 10 Device Observations in 2011 (Citations made in Form 483s)
January 2, 2012 | No comments
The FDA increased the number of inspections in 2011 to a record level. This resulted in a new level of …
Read more »