1Deviation, CAPA, and investigation
Process deviations were not recorded in a separate file or log that details both the deviation and the actions taken.
Inspection Record
Unilever Covington — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations ofelevated kick out/reject rates and Spoilage Reports have not been adequately described and documented, and no HOLD log is available to track and verify investigations ofsuch incidents.
3Aseptic processing and sterility assurance
Entries on aseptic system processing records were not made at the time the specific processing system operation occurred.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
