21 CFR 610.1
§ 610.1 Tests prior to release required for each lot.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 610.1, § 610.1 Tests prior to release required for each lot, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88411
- Permanent ID
ys:prov:88411@1- SHA-256
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Full text
No lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product. Each applicable test shall be made on each lot after completion of all processes of manufacture which may affect compliance with the standard to which the test applies. The results of all tests performed shall be considered in determining whether or not the test results meet the test objective, except that a test result may be disregarded when it is established that the test is invalid due to causes unrelated to the product.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.