Wednesday 24 January 2018

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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