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Tag Archives: Post-Warning Letter

FDA Crisis Intervention
03 Jan

FDA Crisis Intervention

FDA Crisis Intervention Though we hope this never occurs, at times companies do run into situations they were not prepared for, or understand, while dealing with the FDA. We have seen this over and over again with our clients worldwide. These unexpected situations could be: A Surprise FDA Inspection Visit When the FDA gets information

12 Sep

Post-Warning Letter Meetings with FDA

FDA Update – September 6, 2023 Post-Warning Letter Meetings with FDA – Guidance for Industry The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Post-Warning Letter Meetings With FDA – Guidance for Industry. The guidance provides information on the implementation of the post-warning letter meeting process

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