Inspection Record

Sanofi-Aventis Deutschland GmbH — FDA 483 Findings

US FDAInspected 2025-01-16Published 2025-05-23 3 findingsAseptic processing and sterility assuranceCleaning validationOther quality system

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

Findings

1Aseptic processing and sterility assurance

(bTC4l 0 Procedures designed to prevent microbiological contamination of products purpo1i ing to be sterile are not established and followed.

2Cleaning validation

There is a lack ofassurance that the cleaning procedures used for product-contact process equipment for 1141DP an4 the manufacture of (b CbT, DS and DP are effective in preventing product canyover and cross-contamination.

3Other quality system

Cbn 4 DS manufacturing area is not under control to assure product quality.

About this record

Extracted automatically from the document US FDA published on 2025-05-23. 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.

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