1Validation and qualification
During the validation of insulin aspart in human serum (validation report #1000-2403020), the effect of lipemia for selectivity and matrix effect experiments was not evaluated.
Inspection Record
Inotiv Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
Source records for method validation experiments of long-term stability (validation report #1000-091480-2), dilution integrity, stability in matrix and ion suppression (validation report #1000-091480-1), do not document that lithium heparinized human lysed whole blood was utilized as the matrix.
3Validation and qualification
Whole blood stability of insulin aspart was not assessed during method validation (validation report #1000-2403020).
About this record
Extracted automatically from the document US FDA published on 2026-01-16. 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.
