A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.
The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.
Key responsibilities of a US Agent may include:
- Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
- Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
- Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
- Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
- Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.
The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.
Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.
Namrata
Regulatory Consultant
support@libertymanagement.ushttp://www.fdahelp.us