LETTER
FDA Enforcement and Recall Report Week of July 18
FDA Recalls Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the…
FDA Enforcement and Recall Report Week of May 31
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…
FDA Enforcement and Recall Report Week of May 16
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…
FDA Enforcement and Recall Report Week of April 11
FDA Enforcement and Recall Report Week of April 11 Each week the FDA reports on its enforcement activities. To help capture and digest that information…
FDA Picamilon Status
FDA Picamilon Status In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter…
FDA Warning Letters
FDA Warning Letters The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters…
FTC Sues Gerber Over Unapproved Health Claim
The US Federal Trade Commission announced today its intent to sue Gerber for unapproved and unsubstantiated health claims made on its
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.
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…
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…