Regulatory
Quality. Compliance. Excellence.
FDA - cGMP - ISO
Quality Guaranteed
Keystone Industries operates a robust quality management system exceeding industry standards. This system complies with FDA’s cGMP requirements and boasts both ISO 22716 and ISO 13485 certifications, demonstrating adherence to stringent cosmetic and medical device regulations. A dedicated regulatory team ensures compliance with both domestic and international requirements, underlining Keystone’s commitment to product safety and efficacy.
Furthering its dedication to transparency and regulatory compliance, Keystone Industries diligently prepares and maintains comprehensive Product Information (PI) files for all cosmetic products sold within the EU, adhering to Regulation (EC) No. 1223/2009. These files, containing confidential formulation and safety data, are accessible to European officials through Keystone’s Netherlands office. Additionally, Keystone Industries ensures its facilities meet the registration requirements of the Modernization of Cosmetics Regulation Act (MoCRA).
Certifications
”Compliant with EU chemical regulations (REACH), we have registered all applicable substances and maintain open communication with suppliers to ensure ongoing compliance. This secures our operation in the European market.







