French Authorities Order Cosmetic Manufacturer to Comply with Good Manufacturing Practices
Paris, February 7, 2025 – The French Ministry of Economy and Finance has issued an injunction against SAS LABORATOIRES SICOBEL, a manufacturer of cosmetic products, ordering the company to adhere to good manufacturing practices (GMP).
The injunction was prompted by an inspection conducted by the French National Agency for the Safety of Medicines and Health Products (ANSM) in May 2024, which revealed several non-compliances with GMP requirements.
Key Findings of the Inspection
The inspection identified the following deficiencies:
- Inadequate control over原料materials and finished products
- Insufficient cleaning and disinfection procedures
- Lack of validation and control of manufacturing processes
- Deficiencies in personnel training
- Poor quality control and documentation
Injunction Requirements
The injunction requires SAS LABORATOIRES SICOBEL to implement corrective actions to address the identified deficiencies within a specified timeframe. These actions include:
- Establishing a robust quality management system
- Implementing comprehensive cleaning and disinfection protocols
- Validating and controlling all manufacturing processes
- Providing thorough training to personnel
- Enhancing quality control measures and documentation
Consequences of Non-Compliance
Failure to comply with the injunction could result in legal action, including fines and the suspension or revocation of the company’s manufacturing license. The injunction is intended to ensure that SAS LABORATOIRES SICOBEL produces cosmetic products that meet the highest safety standards and protect consumers from potential health risks.
Industry Impact
The injunction against SAS LABORATOIRES SICOBEL sends a strong message to the cosmetic industry about the importance of adhering to GMP regulations. It emphasizes the need for manufacturers to prioritize product safety and implement rigorous quality control measures.
Additional Information
The Ministry of Economy and Finance has published a notice on its website providing further details of the injunction and the corrective actions required by SAS LABORATOIRES SICOBEL.
Sécurité des produits – La SAS LABORATOIRES SICOBEL enjointe de respecter les bonnes pratiques de fabrication lors de la fabrication de produits cosmétiques
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