US FDA Agent
It is mandatory to have all foreign food manufacturers and exporters applying for FDA Food Facility Registration to appoint an FDA US Agent. The US Agent acts as a primary point of contact between the facility and the FDA in case of any emergency and routine registration matters.
We are one among the most reputed US FDA Agents and regulatory consulting service providers to assists food, drugs, medical device, nutraceutical and cosmetic manufacturers and exporters across the Globe.
Type of Foreign Industries US FDA Agent Mandatory
FDA US Agent is mandatory for the following type of facilities who wishes to export to the USA.
- Drug manufacturers
- Medical Device Manufacturers & Exporters
- Food Manufacturers and re-packers
- Nutraceutical manufacturers
- API manufacturers
- Cosmetic manufacturers
- Testing Laboratories
- Sterilization Facilities etc.
Responsibilities of US FDA Agent for Registration
Following are the resposibilities of an FDA Agent
- Gets latest updates from the FDA
- Coordinates with the FDA and addresses registered form for any communication
- Assists the FDA with scheduling foreign facility inspections
- Performs an annual registration update
- Performs initial registration and listing
- DUNS number and Address verification
- FEI number request
- Protects each firm’s login information
How to select a US FDA Registration Agent?
Foreign manufacturers and exporters must carefully evaluate the credentials of the US FDA Agent before appointing them as your company representative. Following are important points to remember:
- Must be a lawfully registered firm in the USA
- Must have the necessary experience and knowledge in Drugs, Food, Medical device & Cosmetics regulation
- Must NOT be a single individual operating from his/her home or workplace
- Must be a company dedicated full-time for regulatory compliance
- Must be aware of FDA Regulatory updates and should communicate to the customers
- Should be neutral and should not have any link with US importers or dealers.
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