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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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 …
Read more »
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, …
Read more »
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 …
Read more »