News & Analysis as of

Food and Drug Administration (FDA) Product Recalls Compliance

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Ankura

Food Safety and Quality: An Ounce of Prevention is Worth a Pound of Cure

Ankura on

The consumer-packaged goods and restaurant industries play a crucial role in the global food supply chain, providing a wide variety of food options that consumers rely on for their daily nourishment. However, the integrity of...more

Husch Blackwell LLP

FDA Issues Stern Reminder for Retailers on Recalls

Husch Blackwell LLP on

Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more

Gardner Law

FDA Compliance: Conducting a Recall

Gardner Law on

Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more

ArentFox Schiff

MoCRA Compliance: Key Legal Issues for Fashion Houses with Cosmetics

ArentFox Schiff on

As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more

Hogan Lovells

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

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