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Code of Federal Regulations (Last Updated: July 5, 2024)

Title 21 - Food and Drugs

Chapter I - Food and Drug Administration, Department of Health and Human Services

SubChapter B - Food for Human Consumption

Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

Subpart N - Returned Dietary Supplements

§ 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Latest version.

§ 111.530 When must an investigation be conducted of your manufacturing processes and other batches?

If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.

                    
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