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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