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Conference updates from Jerry Chapman

Enforcement

Search posts on Warning Letters and 483s

Recent Posts

January 483s: Most Popular and Newsworthy

We put together a review of notable 483s from the month of January, including 483s posted by FDA throughout the month and most-purchased 483s from the Govzilla Store.

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

FDA Warning Letters Week of 1/19/2020: Monitoring Import Alerts

FDA posted four GMP drug warning letters, all to firms outside the US.  One of the letters reinforces the need to monitor import alerts to ensure that suppliers and CMOs are not on the list; the consequences of missing this can be serious as this firm learned.

Govzilla 510k 101

510(k) 101

The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.

December 483s

December 483s: Most Popular and Newsworthy

We put together a review of notable 483s from the month of December, including 483s posted by FDA throughout the month and most-purchased 483s from the Govzilla Store.

RECENT POSTS

Part 1: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

Read More »

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

Read More »

RECENT POSTS

Part 1: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

Read More »

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

Read More »