FDA REGISTRATION PROCESS


  • Completion of relevant application forms by the company
  • Submission of label and content information
  • Regulatory compliance checks of formulation and ingredients
  • Label preparation service
  • DUNS application for the manufacturing company
  • Providing the DUNS number of the U.S. representative or distributor, or applying for a DUNS number if unavailable
  • Completion of FDA food facility registration procedures
  • Preparation of labels in compliance with FDA labeling criteria and regulations
  • Production in accordance with GMP standards
  • Records are published after the completion of the registration process
  • All companies and individuals can verify that the product is registered
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FDA KAYIT
FDA KAYIT

FDA US Representative & Regulatory Compliance Services

FDA registrations are mandatory for product market supply and export to the United States.

FDA (Food and Drug Administration) is the Food and Drug Administration. FDA is the authority responsible for regulating products such as food, drugs, cosmetics and OTC. For FDA registration, DUNS numbers belonging to a company located in the USA and a Turkish manufacturer are required. DUNS numbers will be taken by Ayansan during registration. Products such as hand sanitizer, biocidal product, antimicrobial gel, antibacterial hand liquid, disinfectant are registered with the FDA under the OTC class. All information required to be written on product labels must be arranged according to FDA guidelines. Inappropriate labels are subject to criminal action under market surveillance.


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