Inspection Record

Unilever Covington — FDA 483 Findings

US FDAInspected 2015-07-23Published 2024-01-17 3 findingsDeviation, CAPA, and investigationAseptic processing and sterility assurance

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Findings

1Deviation, CAPA, and investigation

Process deviations were not recorded in a separate file or log that details both the deviation and the actions taken.

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.

Unilever Covington company profile — full history US FDA documents, 2024 Go to Findings search