Inspections (483s and Warning Letters)
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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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 …
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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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Baby Products with SIDS Prevention Claims
October 17, 2011 | No comments
Companies can inadvertenly fall under the FDA’s authority by how they market themselves. Medical devices include any claim to “cure, treat, …
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Responding to 483s – Avoiding a Warning Letter
September 22, 2011 | No comments
It may be suprising when the FDA shows up to inspect your facility. It’s important tow work with the FDA …
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FDA Inspection: Photographs During an Inspection
September 19, 2011 | No comments
The FDA asserts in its inspection manual its right to photograph in your plant. Although the inspection manual provides authority to agents, …
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