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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 111.310: What are the requirements for the laboratory facilities that you use?

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
  4. PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
  5. Subpart J—Production and Process Control System: Requirements for Laboratory Operations

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether:

(a) Components that you use meet specifications;

(b) In-process specifications are met as specified in the master manufacturing record; and

(c) Dietary supplements that you manufacture meet specifications.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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