FDA Enforcement
FDA Regulatory Status Call
Managing Engagement with the US FDA to Avoid Penalties One of the most challenging aspects of working with the FDA is engaging directly with the…
GNC to Strengthen Supplement Quality Controls – Implications for Suppliers
The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the…
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…
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
Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ
An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…
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…
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…