FDA Enforcement

Data Integrity and Form 483 or Warning Letters

Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.

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Nearly 25% of 2014 Warning Letters Issued to Seafood Industry

A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every…

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FDA Uses FSMA Suspension Authority; Second Suspension Under New FSMA Powers

The U.S. Food and Drug Administration (US FDA) suspended the registration of a food facility at Roos Foods in Kenton, Delaware. Facility registration is required…

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FY 2013 483 Data Released; Top Ten Observations Unchanged

The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…

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Rare Recall Arrest: Jensen Farms Cantaloupe Owners Arrested, Charged

A rare and stunning arrest was made this week by the FDA and the US Attorney’s Office. Eric and Ryan Jensen, the owners of the…

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Creekstone Farms Premium Beef Workers File Class-Action Suit For Unfair Compensation

The

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FDA Takes Action Against New York Cheese Manufacturer

The

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US FDA detains Brazil, Canada Orange Juice for Fungicide (Carbendazim)

Food Court reported in early January

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Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g)

The FDA released a

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Department of Justice Files Consent Decree of Permanent Injunction Against Ranbaxy

An Indian generic drug maker faces liquidated damages and a

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FTC Permanently Stops Six Operators from Using Fake News Sites that Allegedly Deceived Consumers about Acai Berry Weight-Loss Products

When considering health claims about a product the FDA often comes to mind. That Agency, however, is not alone in enforcing product claims as the…

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Mill Stream Corp. of Maine Holds Cold Smoked Salmon under FSMA/FDA order

The

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