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e-CFR data is current as of October 26, 2020 |
Title 21 → Chapter I → Subchapter B → Part 111 → Subpart N → §111.530 |
Title 21: Food and Drugs
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?
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.