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FDA Certification

FDA issues Form 483 for FDA Certification of the products after the inspection by officials of the FDA. As per FDA guidelines, the food and drug plants in India should adhere to Current Good Manufacturing Practises (CGMP). FDA helps to ensure the safety, quality, and effectiveness of medical and food products produced in India for export to the United States

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Overview of FDA Certification

The FDA or Food Drug Administration is the oldest comprehensive agency for consumer protection. The FDA Certification is mandatory for placing the products in the USA. Food and Drug Administration (FDA or USFDA) is an agency which is part of the United States Department of Health and Human Services. FDA evaluates and approves many different things, which includes the following:

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

FDA issues form 483 for FDA Certification of the products after the inspection by an official of FDA. As per FDA guidelines, the food and drug plants in India should adhere to Current Good Manufacturing Practises (CGMP). FDA helps to ensure the safety, quality, and effectiveness of medical and food products produced in India for export to the United States.

FDA Certification

Essential requirements for Obtaining FDA Certification

FDA Certification depends on the type of product one is marketing in the United States. All kinds of products do not require the Certification of FDA. Below are the details of what products need FDA Certification.

For Food

The food products do not require FDA Certification. The products, before being distributed in the United States, does not require any kind of certification from the FDA. The food facilities are required to get registered with the FDA. The registration of food facilities with FDA does not mean that FDA Certification of food products. The FDA officials visit and check the food and pharma plants facilities in India. The official check the compliances of the plants with the prescribed rules by the FDA.

For Drug

The FDA check whether the drug conforms to the Over-the-counter (OTC) monograph or not. Drug products should be safe and effective. The OTC monograph establishes such conditions under which the drug products will be safe and effective for consumption.  (OTC) monograph.

On the other hand, the new drug if it does not comply with the OTC monograph, the drug will require Certification fromFDA. The drug manufacturers conduct some lab, human, animal testing and then submit the data to FDA. FDA will review the data provided and may give FDA certification to the product.

For Cosmetics

The cosmetic products and their ingredients (other than Colour Additives) do not require FDA certification before marketing. The cosmetics companies do not require to get registered with the FDA, but the cosmetics products should be safe for use by consumers.

There are certain claims in cosmetic labelling, which may cause the FDA to regulate the cosmetic product as a drug product and in some cases, this may cause the cosmetic product to get approval certificate from FDA.

For Color Additives

The colour additives used in food, drug, some medical devices and cosmetics require FDA Certification. There are certain high-risk colours which require colour batch certification from FDA. The use of colour additives can only be done within the compliances approved byFDA. The harmful colour additives are restricted under the FDA.

For Medical Devices

The Medical Devices are placed into three risk-based categories by FDA. The categories are as follows: Class I, Class II, Class III. The Class III category medical devices are the highest-risk prone devices. These Class III devices only require Certification from FDA. The manufacturers of Class III medical devices should assure the FDA that these Class III devices are safe and effective for use.

The manufacturers of Medical devices should register with FDA, and a detailed list of their Devices should be provided to FDA. The Registering and Listing with FDS doe not indicate the FDA Certification of manufacturers and Devices.

Documents Required for FDA Certification

Entry Documentation

  • Bill of Lading
  • Airway Bill
  • Invoice
  • Purchase Order

Commodity Specific Documentation

  • Packing List
  • Growers List
  • Labelling Copies
  • Documentation stating the identity of the actual owner of the product
  • The statement of the intended use or end use of the product
  • Any other document as requested.

Procedure for Obtaining FDA Certification

FDA has the authority to inspect the facilities of foreign countries which supply food and drug products to the United States. The food and drug plants established in India that export products to the United States should adhere to the FDA guidelines of Current Good Manufacturing Practises (CGMP). The process of FDA Certification is as follows:

  • FDA officials visit the food and drug plants in foreign countries.
  • The official of FDA then issues the Form 483 to the manufactures after the completion of the inspection.
  • The officials if find some deviations from FDA guidelines, it should be in Form 483.
  • Form 430 will specify the areas in which there is a variation from regulatory expectations.
  • The variations are then presented and are discussed with the management of the manufacturing company.
  • The FDA also issues an EIR (Establishment Inspection Report). The EIR specifies whether an action should be taken or not.
  • The response to Form 438 should be submitted to FDA within 15 working days. The response should be detailed with proper reasons for the shortcomings. The new action plan to overcome the shortcomings should also be included in the response.
  • After the response to Form 438 is submitted, a warning letter can be issued by FDA officials. The warning letter is issued if the officials of the FDA are not convinced with the response of Form 438.
  • The response to the warning letter should be satisfactory and should be given within 15 working days. An unsatisfactory response may lead to cancellation of manufacturing license, withholding of product approval and import alert for products.
  • After the FDA officials are satisfied the approval for import of drug is given by the FDA.

Sometimes, the FDA officials if finds that some observations while inspecting the food and drug plant are of severe nature, the FDA may directly issue a warning letter even without issuing Form 438.

Role of Consultant in FDA Certification?

We at Corpbiz provide customized, value-added solutions, procedures and improved quality standards to enhance business efficiency and curtailthe regulatory risks. Our enthusiastic team of expertsattempt to deliver risk-based assessments focusing on the health and well-being of the global population while minimizing the regulatory risk for our clients.

Role of Consultant in FDA Certification

Our professionals have years of knowledge and experience as industry experts responsible for International Quality System Regulation, Inspections of Pharmaceutical and Medical Device Manufacturers, Biomedical Monitoring (BIMO), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audits.

How Corpbiz Will Help You?

Frequently Asked Questions

Form 483 is issued when the FDA officials at the conclusion of inspection observe some conditions which are in violation of FDA guidelines. FDA officials are required to mention all the observations in Form 483 clearly, specifically and significantly.

Form 483 of FDA notifies the management of the company about the objectionable conditions. After the conclusion of the inspection, Form 438 is presented and discussed with the senior management of the company. The management of the company is encouraged to respond to Form 438 in writing. The Form should include the correct action plan. The implementation of the action plan should be done expeditiously.

After the inspection, Form 438 is discussed with the management of the company. The observation of FDA officials in Form 438 is read and discussed for a complete understanding of what observations are and what they mean.

All the colour additives need prior FDA approval before being used in drugs, food or cosmetics. The Colour Certification of FDA is given for batches of colour which are manufactured for use on/in human beings and animals. At designated facilities, the thorough analysis of colour batches is done, and the FDA issues the FDA Colour Certificate.

The validity period of the Certification of FDA is one year from the date of the initial issue of the certificate. The validity period of FDA Certification can be increased based on a request from the company.

A delay in processing the entry of the food or drug products by FDA will be caused in case there is a failure in providing the entry documentation.

To sell and distribute tobacco product, the manufacturers should receive a written order from the FDA. The written order from the FDA does not indicate that the tobacco product is safe or approved by the FDA. The marketing order means that the manufacturer has complied with all requirements to bring the product in the market.

The Local FDA office at the entry of port should be contacted if there are any questions regarding the submission of documents.

The entry documents can be provided to the FDA in the following ways:

  • The documents can be uploaded into ITACS (Import Trade Auxiliary Communication System). For submitting the documents to the FDA, ITACS is the most preferred method. ITACS is the preferred method of submitting documents to the FDA. The documents can be uploaded by the customs broker, importer, or any other responsible party; or
  • Find the contact page of import office and look for local import division postal address, email address and/or fax number for the submission of documents.

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