Inspection Record

Sterigenics US , LLC — FDA 483 Findings

US FDAInspected 2022-08-23Published 2026-07-27 3 findingsComplaint and recall handlingQuality unit oversightDeviation, CAPA, and investigation

View the regulator's official source The source document is always the basis for judgement.

Findings

1Complaint and recall handling

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

3Deviation, CAPA, and investigation

Deviations from written test procedures are not recorded and justified.

About this record

Extracted automatically from the document US FDA published on 2026-07-27. 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.

Sterigenics US , LLC company profile — full history US FDA documents, 2026 Go to Findings search