US FDA Certificate | Benefits | Process | Documents - Lunis Associates
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An Overview:

The US FDA Certificate refers to a document issued to a food or drug company by the United States Food and Drug Administration (FDA) that confirms the reliability and safety of the product they offer.

Since the FDA is at the forefront of protecting public health in the US and inspects and certifies the safety and effectiveness of food, medications, medical devices, cosmetics, and other items, a US FDA certificate is required for every firm that wants to export its products to the US.

Although not all items supplied in the United States require an FDA compliance certification, many types of food, pharmaceuticals, and medical equipment do. For example, all new medications and biological products must be authorized by the FDA before they are commercialized in the United States. Furthermore, all high-risk medical devices must be cleared or authorized by the FDA before they may be sold in the United States.

Here are several FDA compliance certifications issued by the FDA.

  • Certificate to a Foreign Government: It confirms food and additive compliance, which is mandatory for commerce across borders.
  • Certificate of Exportability: It authorizes the lawful export of certain items that aren’t promoted in the United States and fulfill international requirements.
  • Certificate of Free Sale: A certificate of free sale is issued for nutritional supplements and specialty foods, allowing for free exports.
  • Cosmetics Certificate: Validates the conformity of cosmetics to FDA rules, ensuring allowed export.
  • Specialized Health Certificates: For collagen and gelatine goods, these certificates are adapted for both EU and non-EU exports, facilitating seamless worldwide commerce.

If we talk about the cost of an FDA certificate, the FDA doesn’t charge a fee for its certification. However, the process might involve some charges.

Benefits of US FDA Certificate

Obtaining an FDA certificate from a foreign government offers several significant advantages to a company:

Increased customer trust: The FDA’s stringent review process assists in ensuring that products offered in the United States are safe and effective. As a result, it boosts customer trust in the things they buy, leading to more sales.

Market access: FDA certification paves the way to new market avenues, both domestically and globally. Many nations across the world require FDA permission for imported items.

Risk reduction: FDA certification can assist in reducing the likelihood of regulatory compliance difficulties and product recalls. This may save businesses money while also protecting their reputation.

Increased credibility: FDA certification can increase a company’s reputation and credibility. This may make attracting customers and investors simpler.

Increased innovation: The FDA collaborates with businesses to create innovative goods and technology that benefit public health. Companies may benefit from new business prospects as a result of this.

Documents Required

Here’s a list of documents required when applying for an FDA certificate online or offline:

  1. Entry Documentation:

Bill of Lading (BOL)

Airway Bill (AWB)


Purchase Order

2. Commodity-Specific Certifications (where applicable):

USDA Permits

Impact Resistance Test Resultsetc.

3. Additional Documentation:

Packing List/Growers List

Copies of Labeling

Manufacturer Information

Explanation for U.S. Goods Returned

Certificate of Analysis

Intended Use Statement or End Use Statement

other related documents.

US FDA certificate verification.

For manual (non-ABI) entries, CBP Forms 3461 and/or 7501 should also be submitted to the FDA. The specific documents required may vary based on your product category and associated terms. It is advisable to check the FDA guidelines for detailed information tailored to your situation.


The FDA exercises its authority by inspecting foreign facilities supplying food and drug products to the US, ensuring adherence to Current Good Manufacturing Practices (CGMP) in countries like India. Here’s a detailed overview of the FDA certification procedure:

  1. Facility Inspection:

FDA officials conduct on-site visits to food and medicine plants in other nations.

2. Form 483 Issuance:

Post-inspection, the FDA issues Form 483 to manufacturers, detailing deviations from FDA requirements identified during the inspection.

3. Deviation Specification:

Areas not meeting regulatory expectations are specified on Form 430, outlining the discrepancies.

4. Management Review:

Manufacturers’ management engages in discussions regarding the identified modifications.

5. Establishment Inspection Report (EIR):

The FDA issues an EIR, determining necessary actions. The sequence unfolds as follows:

Pre-clinical evaluation

New application assessment

FDA Process Approval

6. Form 438 Response:

Manufacturers have 15 working days to respond comprehensively to Form 438, justifying the deviations and presenting a detailed action plan.

7. Warning Letter Possibility:

If the FDA isn’t convinced by the Form 438 response, they may issue a warning letter.

Manufacturers have 15 working days to provide a satisfactory response. Failure may lead to license revocation, product approval withholding, or import alerts.

8. Approval and Importation:

The FDA grants approval for drug importation upon their satisfaction with the manufacturer’s compliance.

In cases where serious observations are made, a warning letter may be sent directly.

Why Lunis Associates

Securing US FDA certification can be a daunting journey, lasting anywhere from one week to eight months, depending on your approach or expert assistance. In one of the world’s strictest regulatory landscapes, compliance is non-negotiable when it comes to food and medicines. But at Lunis Associates, we pride ourselves on simplifying this intricate process. With a robust history of serving over 10,000 satisfied clients and four years of specialized experience, we offer expertise that matters. Our seasoned consultants not only guide you through the FDA certification maze but also tailor strategies to your specific needs. Join hands with us, and let’s pave the way to your certification success together.


At its core, US FDA certification is like a seal of trust. It’s not just a piece of paper; it’s a declaration that your product is not only safe but also effective for use. Think of it as the FDA’s way of saying that the product adheres to the strict CGMP (current good manufacturing practices) set by the FDA.

According to the Federal Food, Drug, and Cosmetic Act, renewing your FDA certification is a must. It’s not just paperwork; it’s about upholding your commitment to quality. Remember, it’s not just about renewing; it’s about keeping your product’s reputation fresh and ensuring it aligns with the FDA’s evolving standards.

If you’re eyeing the international stage, especially the US, obtaining US FDA certification is non-negotiable. Whether you’re exporting food, drugs, cosmetics, or even PPE kits, the FDA certification ensures that every product you send out meets the rigorous standards set by the FDA. It’s your passport to entering the hearts and homes of American consumers.

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