Wednesday 24 January 2018

All posts tagged FDA Inspection

Warning Letters Begin to Include Notice of FSMA Reinspection Fees

April 10, 2012 | No comments

Beginning in late February warning letters issued by FDA now provide an indication of the types of violations that could […]

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FDA Takes Action Against New York Cheese Manufacturer

January 31, 2012 | No comments

The FDA announced today that it was seeking an injunction in Federal Court against a NY cheese manufacturer. The Agency is asking […]

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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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Listeria Cantaloupe Outbreak Officially Over

December 9, 2011 | No comments

The CDC reports that the Cantaloupe outbreak arising from tainted fruit on Jensen Farms is officially over. The CDC said […]

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CDC “Deadly Listeria Outbreak Halted in Record Time”

November 16, 2011 | No comments

The CDC issued a report today on the Listeria outbreak tied to Jensen Farm’s cantalopes.  Robert Tauxe, MD, MPH, deputy […]

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Six Mistakes That Will Delay Your FDA 510k Submission

October 31, 2011 | No comments

In July 2011, the FDA conducted an analysis of its 510(k) data to determine the causes of increasing medical device […]

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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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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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