# FDA 483 - Sanofi-Aventis Deutschland GmbH - January 16, 2025

Source: https://www.keypedia.com/records/483/sanofi-aventis-deutschland-gmbh/bb6b0c8e-2d76-482b-a0f7-09ec33cea641

> FDA 483 for Sanofi-Aventis Deutschland GmbH on January 16, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi-Aventis Deutschland GmbH
- Inspection Date: 2025-01-16
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality
- Summary: **FDA 483 Summary:**

**Company Name:** [Company Name]

**Inspection Dates:** [Inspection Dates]

**Main Violations/Issues:**

1. **Microbiological Contamination Prevention:** The company lacks established and followed procedures to prevent microbiological contamination in sterile products. Critical surface environmental monitoring post-aseptic filling operations is deficient, with no microbiological surface sampling performed on product contact parts.

2. **Aseptic Processing Technique:** Inadequate aseptic processing techniques were observed, including the use of non-sterile gloves during setup and filling operations, which compromised sterility. Additionally, validation and revalidation processes for filling lines do not ensure complete sterility, as biological indicator placements are ineffective.

3. **Manufacturing Area Control:** The DS manufacturing area lacks adequate environmental controls, such as pressure and humidity systems, which are essential for maintaining product quality.

4. **Product Quality Assurance:** The current manufacturing processes do not assure product quality, as they are less stringent than previous generations.

5. **Cleaning Procedures:** There is insufficient assurance that cleaning procedures for product-contact process equipment are effective in preventing product carryover and cross-contamination. Swab sampling is not performed during cleaning validation for multi-product use or dedicated equipment.

**Regulatory Framework:** The observations are based on FDA regulations concerning sterile product manufacturing and quality assurance.

**Required Actions:**
- Establish and implement robust procedures for microbiological contamination prevention.
- Improve aseptic processing techniques and ensure proper validation of sterility processes.
- Enhance environmental controls in manufacturing areas to ensure product quality.
- Strengthen cleaning validation procedures, including swab sampling, to prevent cross-contamination.

The company is advised to address these issues promptly to ensure compliance with FDA regulations and maintain product integrity.

## Related Documents

- [483 - 2025-01-16](https://www.keypedia.com/records/483/sanofi-aventis-deutschland-gmbh/21ebe3a6-d34a-4245-9ead-e29b2eddba22)

## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

Company: https://www.keypedia.com/companies/sanofi-aventis-deutschland-gmbh/07c96432-bb43-45e5-a80d-e4bca284dbab

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality/c3303908-9657-4cd3-ae43-2458c98e8a64