Tuesday 20 February 2018

All posts tagged 483 Response

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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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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BREAKING NEWS – FDA Breaks All-Time Record, Issuing 10,000 483s

November 4, 2011 | No comments

There are reports that the FDA will surpass 10,000 483s (the citation given before a formal warning letter) in 2011 […]

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Responding to a Warning Letter from the FDA – Food

November 4, 2011 | No comments

If you are reading this you are probably in the middle of an enforcement crisis.   Responding to an FDA-483, Warning […]

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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 Sends Warning Letter to Mushroom, Herb Wholesaler

September 9, 2011 | No comments

Oregon news sources are reporting the FDA ordered a wholesaler of gourmet mushrooms and herbs to clean up unsanitary conditions […]

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