1Laboratory and QC controls
Failure to perform testing of the (b) (4) used in production and in the QC Laboratory.
Inspection Record
Aurorium LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Failure of the Quality Unit to fulfill its oversight responsibilities.
3Other quality system
Failure to investigate all out of specification test results.
4Quality unit oversight
Your firm failed to conduct an annual product quality review of your API.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. 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.
