European Regulation and Quality Control
Our manufacturer in the United States operates with a quality management system compliant with the FDA’s current Good Manufacturing Practices (cGMP) requirements. In addition, it holds international certifications that support its processes:
· ISO 22716:2007, related to quality management systems for cosmetics.
· ISO 13485:2003, specific to medical devices.
These certifications ensure the production, control, and safety of the products. In addition, it has an experienced regulatory team that ensures compliance with international regulatory requirements in all activities performed.
Product support includes the preparation and ongoing maintenance of Product Information (PI) files for all cosmetics marketed in the European Union, in accordance with Cosmetics Regulation (EC) No. 1223/2009 of the European Parliament.
Furthermore, all Fancy Nails products are properly registered and notified in the CPNP (Cosmetic Product Notification Portal), in accordance with Article 13 of Regulation (EC) No. 1223/2009 on cosmetic products.
This allows health authorities in any EU country to access product information, ensuring traceability, safety, and regulatory compliance.