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Get Free QuoteOnline Registration for the Voluntary Cosmetic Registration Program (VCRP)

This is the starting point for firms participating in FDA's Voluntary Cosmetic Registration Program using our online system. To learn more about this program, see Voluntary Cosmetic Registration Program (VCRP).

A company must establish an account with FDA in order to submit Form FDA 2511 or Form FDA 2512 USFDA

Certifications Provided	FDA Registration FEI Number
Target Location	Pan India
Document verification Mode	Online
Training Courses (if applicable)	Food Safety Supervisor Training
Services offered	Consultancy
Type of Certification	New Certification
Type of Industry	For Manufacturing
Mode of Report	Soft Copy
Certification Provided with in	US FDA
Document Required	Company Registration

Get Free QuoteRegistering Your Facility

Each owner/operator must have an account ID and password to use FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a separate account ID and password for the official correspondent.

To obtain USFDA Establishment registration for your facility please complete the below form USFDA

Target Location	Pan India
Document verification Mode	Online
Training Courses (if applicable)	Food Safety Supervisor Training
Services offered	Consultancy
Type of Certification	New Certification

Get Free QuoteAny foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.

Responsibilities of a U.S. agentThe U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

• assisting FDA in communications with the foreign establishment,
• responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
• assisting FDA in scheduling inspections of the foreign establishment and
• if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

USFDA

Get Free QuoteRegistering Your Facility

Each owner/operator must have an account ID and password to use FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a separate account ID and password for the official correspondent.

To obtain USFDA Establishment registration for your facility please complete the below form USFDA

Get Free QuoteRegistering Your Facility

Each owner/operator must have an account ID and password to use FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a separate account ID and password for the official correspondent.

To obtain USFDA Establishment registration for your facility please complete the below form USFDA

Get Free QuoteSection 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration.

The FDA relies on registration and listing information for administering many key programs, including:

• Post-marketing surveillance;
• Potential user fee assessments;
• Counterterrorism;
• Monitoring of drug shortages and availability;
• Determining products that are being marketed without an approved application.

Regulations governing drug establishment registration and listing have long appeared in 21 CFR Part 207 (human drugs, animal drugs, and certain human biologics). In August 2016, FDA published a final rule amending these regulations. This rule updates these regulations with recent statutory amendments and current practice. USFDA