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USA - Regulation

It is The part of the States Department of Health and Human Services and is one of the United States federal execuve departments. New drugs, including biologics, Food addives for people and animals, Color addives in food, drugs, and cosmecs for people and animals, Medical devices, Food and beverages, Cosmecs, Radiaon –eming- electronic devices, Tobacco products. What is U. S FDA?

The FDA evaluates and approves many different things, including: If the management does not convincingly address the Form 483 observaons within the specified me period, the FDA issues a warning leer. Somemes, if the observaons are of a severe nature, the FDA may issue a warning leer even without issuing Form 483. Unsasfactory response to the warning leer could lead to further acon including import alert for products or the facility, withholding of product approval, and suspension or cancellaon of manufacturing license.

The FDA calls for a response to the Form 483 observaons within 15 working days. Though a wrien response is not mandatory, it is preferred so that a warning leer can be avoided. The company has to respond to the observaons in detail with reasons for the shortcomings and correcve acon plans. Each observaon should be addressed individually

The FDA exercises authority for inspecons of facilies in foreign countries which supply pharma and food products to the US. So, pharma and food plants in countries that export to the USA must adhere to the CGMP (current good manufacturing pracces) as per FDA guidelines. FDA officials visit the facilies to check compliance with the rules.FDA issues form 483 at the compleon of inspecon. If it finds deviaons from CGMP, it is menoned in the form 483. The form specifies areas in which the facility fell short of regulatory expectaons. It is then presented and discussed with the management of the company, Along with the form 483, the FDA also issues an Establishment Inspecon Report (EIR) which specifies whether acon is required to be taken.

The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States.

U.S. agent and roles and responsibilities of the U.S. agent:
  • AS. agent may be an individual, partnership, corporation, or association.
  • AS. agent must have a place of business or residence in the United States and be physically present in the United States. For example, a foreign facility may use its U.S. importer as its U.S. agent. As established in 21 CFR 1.227,
  • TheS. agent acts as a communications link between FDA and a foreign facility for both routine and emergency communications.
  • The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact. In functioning as the communications link with FDA, a U.S. agent may choose to initiate communications with FDA, and FDA may likewise choose to initiate communicationswith the S. agent.

Section415(a)(3) of the FD & C Act requires facilities that are required to register with FDA to renew their registrations every other year, during the period beginning on October 1 and ending Contains

(Nonbinding Recommendations 37) on December 31 of each even-numbered year.

1.1 Policy:

FDA’s prior notice for imported foods system is the agency’s primary tool for ensuring that foreign facilities that offer food for import into the United States are registered under section 415 of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002). If FDA determines that a foreign food facility is not registered in accordance with section 415 and 21 CFR part 1, subpart H, the food being imported or offered for import into the United States from the foreign facility is subject to being held at the port of entry (as defined in 19 CFR 101.1), in accordance with section 801(l) of the FD&C Act, unless

U.S. Customs Border Protection (CBP) concurrence is obtained for the export of the food and the food is immediately exported from the port of arrival (as defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this circumstance shall not be entered and shall not be delivered to the importer, owner, or ultimate consignee until the foreign facility is registered in accordance with section 415 and 21 CFR part 1, subpart H, and the appropriate registration number is provided in prior notice as specified in 21 CFR 1.285(i).

1.2. Submission of registration or registration renewal by mail or fax

Beginning January 4, 2020, registrants must submit their registration or registration renewal to FDA electronically; unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231). If FDA has granted a waiver under 21 CFR 1.245, the registrant may register or renew by mail or by fax. If you submit a registration or registration renewal by mail or fax, you must use the paper version of Form FDA 3537. That version is available for download at

https://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm.

You can request the paper form and submit the completed form by fax to 301-436-2804 or by mail to:

U.S. Food and Drug Administration Food Facility Registration (HFS-681) 5001 Campus Dr. College Park, MD 20740.

FDA office in India:

FDA opened the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the U.S. are safe, are of good quality, and are effective.

FDA’s goals in India are to obtain information to help make better regulatory decisions about the products from India that are being developed and exported for the U.S. market. This includes medical products being reviewed for marketing authorization in the U.S., and the safety assessment of products that are already on the U.S. market. In addition, the India Office helps verify that foods being imported into the U.S. are safe.

1.2. Information required in the registration of a food facility :

As outlined in 21 CFR 1.232, the following information is required for domestic and foreign food facility registrations:

  • The facility name, address, phone number, and emergency contact phone number; • Preferred mailing address, if different from that of the facility;
  • Parent company name, address, and phone number (if the facility is a subsidiary of the parent company);
  • Alltrade names the facility uses;
  • Name, address, and phone number of the owner, operator, or agent in charge;
  • The email address of the owner, operator, or agent in charge, unless FDA has granted a waiver under 21 CFR 245;
  • Applicable food product categories of any food manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537;
  • The type (s) of activity at the facility for each food product category, as provided in 21 CFR 232(a)(8);
    • A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manne

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