All posts tagged Warning Letter
Staples Warned by FDA over Snacks Gnawed by Rats
March 13, 2012 | No comments
Retailers who carry snack may want to rethink their compliance strategies. Under new FSMA provisions and increased FDA scrutiny retailers …
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Food Court News March 9 – Weekly Briefing (audio)
March 9, 2012 | 1 comment
Subscribe to Food Court News on iTunes. In this weeks summary of food news: Inhaleable Caffine: The U.S. Food and Drug Administration has …
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Importance of MDR Reporting; J&J Delayed Reporting Insulin Pump Problems
January 11, 2012 | No comments
The Associated Press is reporting that the FDA has warned Johnson & Johnson that it could face fines and other sanctions …
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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 …
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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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FDA issues Warning Letters for Misleading Advertising of Lap-Band
December 13, 2011 | No comments
The FDA issued warning letters for misleading Lap-Band advertising which the Agency states lacks information on the risks of gastric …
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Misbranding – FDA Issues Warning Letter on “All Natural” Claim
December 2, 2011 | No comments
The FDA issued a warning letter to food manufacturer, Alexia Foods Inc., for labeling as “all natural” a product that contained a …
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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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FDA’s Listeria Report on Jensen Farm Outbreak
October 19, 2011 | No comments
The FDA released it’s report on the Jensen Farm Outbreak. “FDA identified the following factors as those that most likely …
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