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FDA Certification

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From Startup Specialist

    The Food and Drug Administration (FDA or USFDA) is a federal agency which is the part of the United States Department of Health and Human Services. It is one of the departments. The FDA evaluates and approves many different things, including:

    • New drugs, including biologics,
    • Food additives for people and animals,
    • Colour additives in food, drugs, and cosmetics for people and animals,
    • Some medical devices.

    The FDA exercises authority for inspections of facilities in foreign countries which supply pharma and food products to the US. So, pharma and food plants in India that export to the US must adhere to the CGMP (current good manufacturing practices) as per FDA guidelines. FDA officials visit the facilities to check compliance with the rules. FDA issues form 483 for FDA Certification of the products after the inspection by an official of FDA.

    • To receive FDA approval for a drug or a high-risk medical device, a drugs or device’s manufacturer must prove to the FDA that the item is “safe and effective.”  
    • Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.
    • The FDA does not do its own testing of new drugs, medical devices, or other items.  Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer.
    • The FDA approval process requires the manufacturer to work with the FDA during human trials of drugs and other devices to ensure trials meet rigorous scientific standards and that human subjects are protected from unnecessary risks.
    • The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer’s clinical trials and other research.  Based on this analysis, the agency decides whether to approve a drug or medical device for a particular use.
    • Drugs and biologics
    • Animal drugs and food additives in animal food, which includes pets, poultry, and livestock.
    • Medical devices. Class I devices, such as dental floss and bandages, are subject to the least regulation. Catheters and wheelchairs are examples of Class II devices that require FDA “clearance” prior to marketing. Implants and life-sustaining devices such as heart valves are examples of Class III devices, which require premarket approval by the FDA and are subject to the highest levels of regulation.
    • Human tissues and cells for use in humans, such as corneas, skin and bone that can transmit infectious diseases are regulated
    • Food ingredients and additives, such as preservatives and texturizers must be proven to be safe. Additives are also anything in the packaging, such as paper, adhesive, or the plastic, that can intentionally or unintentionally encounter the food.
    • Colour additives that are used in any FDA-regulated products, which include drugs, food, dietary supplements, and cosmetics.

    You should provide FDA with entry documentation which may include the following: 

    • Bill of Lading (BOL),
    • Airway Bill (AWB), invoice, and purchase order. 
    • Where applicable, you should also provide FDA with commodity specific certifications (USDA permits, Impact Resistance test results, etc.),
    • packing list/growers list, copies of labelling, documentation stating who the actual manufacturer is, documentation explaining why articles classified as U.S. Goods Returned are being returned,
    • certificate of analysis, intended use statement or End Use Statement, and other related documentation as requested
    This is a staging enviroment