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Manufacturers Quality Control Plan Compliance

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hot Topics in Products Liability Law: Data Can be Used in Products Liability Cases as a Sword and as a Shield

In a past blog post, we predicted that data is arguably the products liability issue of the future. Dealing with data is already often a critical part of products liability lawsuits, but with the rise of artificial...more

Gibney Anthony & Flaherty, LLP

Manufacturing Products with a US Licensee: Key Considerations for Emerging Businesses

In the early stages of doing business, emerging businesses often use a distributor to introduce a product to the US market without a full sales force. This requires a solid distribution agreement. As your business expands,...more

Thomas Fox - Compliance Evangelist

For the Benefit of Mr. Kite – Fiction in the World of Quality Assurance

The basics were laid out by Peter Wells and Emiko Terazono in a Financial Times (FT) article entitled “Kobe Steel scandal hits Boeing, Toyota and Nissan”. The Japanese company admitted it had falsified “inspection data on an...more

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