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# Allure Labs FDA-483 Out
- URL: https://www.fdaweb.com/allure-labs-fda-483-out/
- Published: 2026-07-29T12:00:00.000Z
- Updated: 2026-09-14T13:44:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161543

FDA has released the form FDA-483 issued following a 3/23-3/27 inspection at the Allure Labs manufacturing facility in Hayward, CA. The three specific inspection observations were:

- failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are initiated only by authorized personnel; and
- failure to establish the accuracy of test methods.