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# AveXis Inspection Observations
- URL: https://www.fdaweb.com/avexis-inspection-observations/
- Published: 2019-08-08T12:00:00.000Z
- Updated: 2026-09-15T01:42:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144720

FDA has released the FDA-483 issued following a 7/24-8/2 inspection at AveXis, San Diego, CA, the control testing laboratory at the center of data manipulation concerns ([see story](https://www.fdaweb.com/fda-confident-zolgensma-should-stay-on-market/)) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. An agency [statement](https://www.fda.gov/news-events/press-announcements/statement-data-accuracy-issues-recently-approved-gene-therapy?ref=fdaweb.com) says FDA was informed 6/28 about the data manipulation issue that affects the accuracy of certain data from product testing performed in animals submitted in the BLA reviewed by FDA.

The [document](https://www.fda.gov/media/129664/download?ref=fdaweb.com) contains five inspection observations: 

- failing to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed;
- laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- laboratory records do not include complete records of any testing and standardization of laboratory reference standards; and
- failing to follow established test procedures.