Thursday 23 February 2012

Inspections (483s and Warning Letters)

Accurate Set Inc.

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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PIPScandalReform

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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RanaxbyInjunction

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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Animas

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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FDAEMA

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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regs

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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lapband

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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FDAUpdate

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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USDA5

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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MP900308900

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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