1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter B - FOOD FOR HUMAN CONSUMPTION
  5. Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
  6. Subpart N - Returned Dietary Supplements
  7. 21 CFR § 111.530
21 CFR § 111.530
When must an investigation be conducted of your manufacturing processes and other batches?
June 25, 2020
CFR

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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§ 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
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§ 111.535 Under this subpart N, what records must you make and keep?

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