483

FDA Enforcement and Recall Report Week of June 27

Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty…

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FDA Enforcement and Recall Report Week of June 23

Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and…

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Review: FY 2014 Inspectional Observation Summaries

At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…

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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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