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Policies and Procedures Product Recalls

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

McDermott Will & Emery

FDA Issues Final Guidance for Initiation of Voluntary Recalls

The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more

Foley & Lardner LLP

New Product Safety Requirements and Recall Procedures Adopted in Mexico: Time for Manufacturers to Update their Compliance...

Foley & Lardner LLP on

The commercial and legal environment on product safety in vehicles, auto parts and other products has substantially changed in Mexico in 2018. Manufacturers carrying out business activities in Mexico should now be...more

Foley & Lardner LLP

Lessons That Manufacturers Can Learn From Automotive Recall Issues

Foley & Lardner LLP on

By now, anyone not living under a rock for the last 18 months is no doubt aware of the high-profile recalls that have been roiling the automotive industry. Although the long-running GM ignition switch recall may be the most...more

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