LOOKING TO SELL COSMETICS IN THE U.S.?
United Safety Agents (USA) specializes in assisting cosmetic companies in achieving MoCRA regulatory compliance.
Cosmetic Facility
Product Listing
FDA Registration
FDA cosmetic regulation includes a mandatory two-part registration,
including Cosmetic Facility Registration and Product Listing Registration.
PRODUCT LISTING REGISTRATION
for cosmetic distributors
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PRODUCT REGISTRATION
USA will submit an Initial Product Listing Registration and Amended Registrations.
USA will act as your company's U.S. Agent.
2. CERTIFICATE
Once FDA approves your Product Listing Registration, you will receive a Certificate indicating your MoCRA compliance.
3. ADVERSE REPORTING
Have a Serious Adverse Event?
USA will assist you through the process of reporting event with FDA.
FACILITY REGISTRATION
for cosmetic manufacturing and processing facilities
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FEI NUMBER
Does your Facility have an FEI number? If not, no problem.
USA will help to obtain one at no additional cost.
2. FACILITY REGISTRATION
USA will submit an initial Facility Registration and Amended Registrations.
USA will act as your Facility's U.S. Agent.
3. CERTIFICATE
Once FDA approves your Facility Registration, you will receive a Certificate indicating your MoCRA Compliance.
MoCRA is mandatory. MoCRA has broadened the FDA's regulatory authority over the cosmetic industry with the intention of protecting the public's health and confirm consumer confidence by placing safety measures on all cosmetics sold in the United States. MoCRA requires FDA Facility Registration, Product Listing Registration, Serious Adverse Event Reporting, Records Maintenance, adds to Labeling Requirements, and establishes GMPs.
Failure to meet these requirements falls into the Prohibited Acts under Section 301 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331).
