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Ten Tips for Passing 21 CFR Audits

A maintenance management system can help streamline operations and ensure compliance

Photo by National Cancer Institute on Unsplash

James Chan
Thu, 08/29/2024 - 12:02
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The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses, organizations, and individuals involved in producing these goods and delivering them to consumers.

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Many of these conditions are outlined in Title 21 of the Code of Federal Regulations (21 CFR) along with the full spectrum of rules and regulations falling under the FDA’s oversight. In the guide below, we’ll explore some of the most consequential provisions of 21 CFR and offer actionable tips for how your organization can pass your next FDA audit.

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