All posts tagged Form 483
How does FDA Identify a High-Risk (HR) Facility under the Food Safety Modernization Act?
March 9, 2012 | No comments
The FDA released new information today on how the Agency would determine which facilities are “high risk facilities” that require …
Read more »
Top Food Observations in 2011 (Citations made in Form 483s)
January 3, 2012 | No comments
Yesterday Food Court reported on the top ten observations made during a facility audit. Observations are the citations made in …
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 »
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 …
Read more »
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 …
Read more »
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 …
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 »