1Laboratory and QC controls
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.
Inspection Record
Avexis — FDA 483 Findings
Inspectors Scott T Ballard · Mihaly S LigmondThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Laboratory and QC controls
Established test procedures are not followed.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2019-08-08. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
