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Electronic Code of Federal Regulations

e-CFR data is current as of May 21, 2020

Title 21Chapter ISubchapter BPart 111Subpart 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.

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