FDA Certification

Prevent issues and complications to market your product in the USA with the help of FDA Certification in Sri Lanka.

What is FDA Certification

FDA Certification shows compliance with the United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The USFDA is responsible for protecting public health by assuring the food and drugs are safe for usage and properly verified and labeled for promoting public health through the control and supervision of food safety, pharmaceutical medications, tobacco products, medical devices, dietary supplements cosmetics, animal foods & feed and veterinary products.

The scope of the FDA is broad and is interlinked with various government agencies for the compliance of the FDA guidelines and local government regulations. The FDA exercises authority for inspections of pharma and food products supplied to the US. For compliance with the FDA standard, the organization must conduct CGMP practice. The Food and Drug Administration registration is the basic requirement to manufacture or market food, drug, API, or medical devices in the USA.

Implementation of USFDA helps in protecting the public from electronic product radiation, regulating tobacco products, and safeguarding public health by speed up the improvement and product innovations. For this verification, the FDA issues form 483 after inspection and Establishment Inspection Report (EIR) which specifies whether action is required to be taken if the organization fell short of regulatory expectation.

If the management fails the compliance with FDA regulation or does not convincingly address Form 483 within the prescribed time, it could lead to further action including import alert for products or the facility, withholding of product approval, and suspension or cancellation of manufacturing license. To become the dominant player in the US market the management needs to accomplish the guidelines of FDA requirements as a major investment in facilities with the hope of continuing export growth to the US.

Benefits of FDA Certification

  1. Helps to achieve brand visibility
  2. Increase your market size globally
  3. Helps to implement best and efficient industrial practice
  4. Gain customer confidence
  5. Compliance with local rules and regulations
  6. Builds marketability and Creditability
  7. Demonstrating reliability and high quality of service
  8. Enjoy advantages of competitors edge

Requirements of FDA Certification

  • Follow Good Manufacturing Practice (cGMP)
  • Establishing Quality Assurance and Quality Control functions
  • Conduct Risk Assessment Management System
  • Establish Process Analytical Technology (PAT)
  • Preparation and Review of FDA Regulatory 510k, PMA, IDE, DMF, ANDA, IND, and Prior Approval Supplement (PAS) applications
  • Response to 483 or warning letter
  • Conduct Internal Audit

Why obtain FDA Certification in Sri Lanka?

The Food and Drug Administration is the oldest comprehensive consumer protection agency to monitor the safety of agricultural products. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety to get it placed in the US market.

fda Certification process

Strength of Ascent Associates

  • As a non-profit organization, Ascent ASSOCIATES operates with the motto of their clients and customer welfare.
  • Ascent guide and help you through the whole process to obtain FDA Certification.
  • Ascent has experienced personnel to conduct Gap Analysis and inadequate resources will resolve various problems.
  • Ascent works closely to provide you with Technical FDA consultancy towards the achievement of certification without the mentality of profit.
  • Ascent helps you in getting the certificate from a leading Accreditated Body accepted globally.
  • Ascent performs 24X7 to help our customers and clients’ need. Ascent has the habit to perform a complete analysis before an offer quote is provided.
  • Guidance during Validation of Test Results- Inter-Laboratory Comparisons and calculation of Z-Score.
  • Guidance for calculation of Measurement of Uncertainty.
  • Training on Calculation of Measurement of Uncertainty.

Get in touch today to achieve FDA certification for your organization and gain the benefits of it.

Frequently Asked Questions

Why FDA doesn't include dietary supplements?

Dietary supplements do not require the approval of the FDA. FDA’s Centre for Food Safety and Applied Nutrition is responsible for the FDA’s oversight of dietary supplements.  

Does the US require export certificates to export to foreign countries?

NO, the US does not require an export certificate to export products further to foreign countries.

What is the validity of FDA certification?

FDA is valid for a year from the issuing date and can be extended as per the payment and on request. FDA food facility registration is to be kept confidential from the general public.

What is the cost of FDA approval?

The cost of FDA approval depends on the type of product you want FDA approval.

Why should you hire a Consultant for achieving FDA Certification?

Getting FEI a unique identifier issued by FDA to track inspections is not self-identified. Achieving third-party registration firm helps to make complicated ask easy in registration which results in getting of the FDA registration Sri Lanka Number (FEI) number by the FDA.

How to achieve FDA approval?

To get FDA approval, relevant product manufacturers must implement a Quality Management System w.r.t. relevant GMP standards then, conduct all testing in the recognized and accredited lab and submit their data to the FDA. FDA will then review the data based on which it may or may not approve the product. If the agency (FDA) feels the data submitted is not relevant and may be risky for the intended use, it might not give approval / Certification.


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