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# FDA Releases Liveyon FDA-483
- URL: https://www.fdaweb.com/fda-releases-liveyon-fda-483/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143795

FDA has released the FDA-483 issued following a 9/17-9/21/18 agency inspection at Liveyon, a Yorba Linda, CA, “own label stem cell distributor.” The inspection observations were: 

- adverse reactions that involved a communicable disease related to an HCT/P (human cells, tissues, or cellular or tissue-based products) made available for distribution and were fatal or life-threatening, resulted in permanent impairment or damage to the body, or necessitate medical or surgical intervention, were not reported to FDA;
- complaint records are deficient in that they do not include the findings of the investigation and follow-up;
- the summary of records for HCT/Ps did not contain an interpretation of results of all communicable disease testes performed;
- release criteria were not verified to have been met through a review of manufacturing and tracking records before HCT/Ps were made available for distribution;
- testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release;
- equipment was not routinely inspected for calibration;
- storage temperatures of HCT/Ps were not recorded and maintained; and
- appropriate shipping conditions were not defined for each type of HCT/P.