FDA Cosmetic Products Facility Registration Services
InterlinkIQ provides specialized services to assist cosmetic manufacturers and distributors in navigating
the FDA facility registration process. Our services ensure that your facility meets FDA requirements for
cosmetic products, facilitating compliance and market access. Here is a detailed list of our FDA Cosmetic
Products Facility Registration services:
Initial Consultation:
Regulatory Overview
Provide an overview of FDA requirements for cosmetic product
facility registration.
Registration Strategy
Develop a strategy tailored to your facility’s needs and goals for
FDA compliance.
Facility Registration:
Registration Process
Assist in completing and submitting the FDA facility registration
form (Form 2613a).
Registration Updates:
Help with updating facility registration information as needed.
Product Listing and Information:
Product Information Submission
Assist in submitting product information to the FDA's
Voluntary Cosmetic Registration Program (VCRP) if applicable.
Ingredient Declaration
Ensure accurate and complete ingredient declarations in
product listings.
Compliance Assessment:
Regulatory Compliance Review
Evaluate your facility’s compliance with FDA
regulations and guidelines for cosmetics.
Gap Analysis
Identify any compliance gaps and provide recommendations for
addressing them.
Documentation Support:
Record Keeping
Assist in establishing and maintaining necessary records and
documentation required by the FDA.
Label Review
Ensure that product labels meet FDA requirements and include necessary
information.
Training and Education:
FDA Regulations Training
Provide training on FDA regulations and requirements for
cosmetic facilities.
Compliance Workshops
Conduct workshops to educate staff on FDA requirements and
best practices.
Audit Preparation:
Pre-Registration Audit
Perform an internal audit to assess readiness for FDA
registration.
Audit Readiness Review
Ensure that all systems, documentation, and processes are in
place for a smooth registration process.
Ongoing Compliance Support:
Regulatory Updates
Keep you informed about changes to FDA regulations and
requirements affecting cosmetic facilities.
Compliance Monitoring
Provide ongoing support to ensure continued adherence to
FDA guidelines.
Corrective Actions and Follow-Up:
Action Plan Development
Assist in developing and implementing corrective action
plans for any identified compliance issues.
Follow-Up Support
Monitor the effectiveness of corrective actions and ensure
resolution of any issues.
Regulatory Communication:
FDA Liaison
Act as a liaison between your facility and the FDA to address any regulatory
inquiries or issues.
Issue Resolution
Provide support in resolving any issues or concerns raised by the FDA.
Documentation and Record Maintenance:
Documentation Management
Assist with the organization and maintenance of
documentation required for FDA compliance.
Record Audits
Conduct audits of documentation and records to ensure completeness
and accuracy.
Market Access Support:
Export Compliance
Provide guidance on FDA requirements for exporting cosmetics and
ensuring compliance with international regulations.
Product Approval Assistance
Assist with the preparation of documentation for FDA
approval of new cosmetic products.
InterlinkIQ is dedicated to helping your cosmetic products facility achieve and maintain FDA registration,
ensuring compliance with regulatory requirements and facilitating smooth operations. Contact us to
learn more about how our FDA facility registration services can benefit your business.
