After inspecting food and drug manufacturing plants, the FDA issues Form 483 for product certification. According to FDA guidelines, these plants in India must comply with Current Good Manufacturing Practices (CGMP).
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Auriga Accounting has a team of registration experts who can provide complete guidance to register your FDA Certificate.
Our team of experts will get in touch with you and collect all necessary documents and details
We fill out and file your application for Certificate
Your FDA Certificate is Done
The Food and Drug Administration (FDA), established in 1906 under the Federal Food and Drugs Act, is a government agency dedicated to consumer protection. As the oldest and most comprehensive agency for public health, FDA Certification is essential for placing products in the U.S. market.
Part of the United States Department of Health and Human Services, the FDA’s primary responsibility is safeguarding public health by ensuring the safety and security of human and biologically derived products. The FDA regulates a broad range of products, including biological products, medical services, cosmetics, prescription and non-prescription drugs, veterinary drugs, tobacco, and radiation-emitting products.
Following inspections, the FDA issues Form 483 as part of the certification process for products. In accordance with FDA guidelines, food and drug plants in India must adhere to Current Good Manufacturing Practices (CGMP). The FDA plays a crucial role in ensuring the safety, quality, and effectiveness of medical and food products exported from India to the U.S.
FDA Certification for Food: Food products themselves do not require FDA certification, but food facilities must be registered with the FDA. Prior to distribution in the United States, food products do not need FDA certification. FDA officials conduct inspections of food and pharmaceutical plants in India to ensure compliance with FDA regulations.
FDA Certification for Drugs: FDA assesses whether a drug complies with the Over-the-Counter (OTC) monograph, which defines conditions under which drug products are safe and effective for consumption. If a drug does not conform to the OTC monograph, it requires FDA certification. Manufacturers must conduct laboratory, human, and animal testing, submit the data to the FDA, which then reviews it before issuing certification.
FDA Certification for Cosmetics: Cosmetic products and their ingredients (except for color additives) do not require FDA certification before marketing. While cosmetics companies are not required to register with the FDA, products must be safe for consumer use. If certain claims are made about the product, the FDA may regulate it as a drug, which could necessitate FDA approval.
FDA Certification for Color Additives: Color additives used in food, drugs, cosmetics, and some medical devices must be FDA certified. Certain high-risk color additives require batch certification from the FDA. Only FDA-approved color additives can be used, with harmful additives being restricted.
FDA Certification for Medical Devices: Medical devices are categorized by the FDA based on risk: Class I, Class II, and Class III. Class III devices, being the highest risk, require FDA certification. Manufacturers of these devices must demonstrate to the FDA that the products are safe and effective for use before certification is granted.
Impact within the Industry: FDA approval requires rigorous testing and iterations, but once achieved, it significantly benefits consumers by enhancing their health and conditions, making the product available for purchase.
In-Demand Product: FDA-approved products quickly gain consumer trust due to their proven safety, leading to increased demand. The FDA seal of approval often turns a product from a nice-to-have to a must-have.
Access to Worldwide Markets: FDA approval grants a Certificate of Foreign Government (CFG), opening doors to global markets such as Japan, Brazil, Australia, and China, allowing your product to be marketed and exported from the U.S.
Increase Credibility: FDA approval enhances your product’s credibility globally, showcasing that it has undergone thorough testing and quality enhancements before being approved.
Expand Your Company’s Expertise: Achieving FDA approval opens new opportunities for your company to expand into other business areas. It encourages continuous product improvement and innovation, potentially branching into other industries.
Enhanced Idea to Advance the Product: FDA approval emphasizes the importance of safety and efficacy in every step of product development, from creation and design to testing and production.
Creates Lines for Funding: FDA-approved products make it easier to secure funding as they demonstrate credibility and commitment to quality. Large companies often seek to invest in smaller businesses with FDA-approved products.
Acknowledged in Medical Networks: FDA clearance is essential for selling food or medical products in pharmacies and medical facilities. It also helps expand your network through collaborations on clinical trials and product testing.
Bill of Lading
Airway Bill
Invoice
Purchase Order
Commodity-Specific Documentation
Packing List
Growers List
Copies of Labels
Proof of Product Ownership
Statement of Intended or End Use
Any Additional Documents as Requested
The FDA is authorized to inspect food and drug facilities abroad that export products to the United States. Indian food and drug plants must comply with FDA’s Current Good Manufacturing Practices (CGMP). The certification process follows these steps:
FDA Inspection: FDA officials conduct an inspection of the foreign food and drug facilities.
Issuance of Form 483: If deviations from FDA guidelines are detected, Form 483 is issued, highlighting areas of non-compliance.
Discussion: The identified issues are reviewed and discussed with the management of the facility.
Establishment Inspection Report (EIR): The FDA generates an EIR to determine whether any corrective action is necessary.
FDA Procedure: The process continues with Pre-Clinical Testing, Investigational New Application (INA), and FDA Review.
Response to Form 483: The manufacturer must submit a response within 15 working days, addressing the deficiencies and outlining corrective actions.
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