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The FDA plays a vital role in safeguarding the health and well-being of the American public by regulating a wide range of products and ensuring that they meet established safety and efficacy standards. Its work has a significant impact on public health, the healthcare industry, and the economy.

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US FDA

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The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services (HHS) of the United States government. Its primary mission is to protect and promote public health by regulating and supervising various aspects of the food supply, pharmaceuticals, medical devices, biologics (including vaccines and blood transfusions), radiation-emitting devices, veterinary products, and cosmetics. The FDA plays a crucial role in ensuring the safety, efficacy, and quality of these products and the safety of the nation's food supply.

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Here are key aspects of the U.S. FDA:

  1. Regulatory Oversight: The FDA is responsible for regulating and overseeing the safety and effectiveness of a wide range of products, including but not limited to:
    • Food and Beverages: Ensuring the safety of the nation's food supply, including food labeling, additives, and foodborne pathogens.
    • Pharmaceuticals: Reviewing and approving new drugs, monitoring their safety post-approval, and ensuring that they are manufactured to high-quality standards.
    • Medical Devices: Evaluating the safety and effectiveness of medical devices, from simple tools to complex equipment.
    • Biologics: Regulating vaccines, blood products, gene therapies, and other biological products.
  2. Product Approval: The FDA evaluates and approves new drugs, medical devices, and biologics through a rigorous review process to determine their safety and efficacy before they can be marketed to the public.
  3. Post-Market Surveillance: The FDA monitors the safety and effectiveness of products on the market and takes action, including recalls, when safety concerns arise.
  4. Food Safety: The agency is responsible for ensuring the safety of the nation's food supply. This includes inspecting food facilities, establishing food safety standards, and responding to foodborne illness outbreaks.
  5. Labeling and Packaging: The FDA regulates product labeling, including nutrition labels on food products and information on drug labels.
  6. Research and Innovation: The FDA conducts research and collaborates with other agencies, academia, and industry to advance regulatory science and stay current with technological and scientific advancements.
  7. International Collaboration: The FDA works with regulatory agencies in other countries to promote global public health and ensure the safety and efficacy of products that are imported into or exported from the United States.
  8. Public Health Education: The FDA educates consumers and healthcare professionals about product safety and provides information on recalls and safety alerts.
  9. Emergency Response: The FDA plays a role in responding to public health emergencies, such as outbreaks of foodborne illnesses, drug shortages, and other health threats.
  10. User Fees: In some cases, manufacturers pay user fees to support the FDA's review of their products. This is common in the pharmaceutical and medical device industries.

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