We ZS Technologies as your US FDA Agent will act as a primary contact with FDA by facilitating communications such as receiving and responding to FDA inquires, emergency notifications and inspection coordination. With proven expertise in foreign facility registration for US FDA certification, our dedicated team is ready to assist you 24/7. We provide personalized guidance and prompt support to ensure all your questions are answered and the process is seamless.
We act as a reliable point of contact for all FDA-related issues with guaranteed availability during business hours. We ensure timely management in preparation and coordination of all regulatory tasks and submissions helping deadlines are met and the business stays compliant. We provide guidance and assistance in FDA related documentation, compliance measures and understanding complex regulations.
We forward all FDA communications related to your establishment to prevent compliance issues, product holds on import or detentions and regulatory penalties.
Our expertise includes:
- DUNS Assistance: FDA requires all food facilities provide a DUNS number as a unique facility identifier that FDA can use to verify the existence and operations of a registered facility. Dun & Bradstreet is the organization responsible for assigning and maintaining DUNS numbers. ZS- TECHNOLOGIES can assist in obtaining a DUNS number or update an existing DUNS record. Food Facility Registrations information must match the information listed on the DUNS.
- Certificate of Registration : Companies often are asked by their customers and suppliers to verify their U.S. FDA food facility registration. Food facility registrations are not in a publicly available database. FDA does not issue or recognize Certificates of Registration. Certificates of Registration issued by ZS- Technologies provide confirmation to industry and prevent accidental loss of critical information.
- Certificate of Registration: Certificates issued by ZS- TECHNOLOGIES provide confirmation of your facility’s registration to industry
- Registration Updates: Registrations must be updated within 60 days of a change in required information
- Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment.
Some Important FAQ’s
Common Frequently Asked Questions
ZS Technologies acts as the primary contact with the FDA, facilitating communication such as receiving and responding to FDA inquiries, emergency notifications, and inspection coordination. They provide personalized guidance and 24/7 support for foreign facility registration and assist in all FDA-related issues with guaranteed availability during business hours.
They ensure timely management, preparation, and coordination of regulatory tasks and submissions to meet deadlines and keep the business compliant. They provide guidance and assistance with FDA-related documentation, compliance measures, and understanding complex regulations.
They forward all FDA communications related to the establishment to prevent compliance issues, product holds on imports, detentions, and regulatory penalties.
A DUNS number is a unique facility identifier required by the FDA for all food facilities, used to verify the existence and operations of a registered facility. Dun & Bradstreet assigns and maintains DUNS numbers. ZS Technologies assists in obtaining a new DUNS number or updating an existing one.
The registration information must exactly match the information listed on the DUNS record.
No, the FDA does not issue or recognize Certificates of Registration. However, ZS Technologies issues Certificates of Registration that provide confirmation of a facility’s registration to industry, helping prevent accidental loss of critical information.
Registrations must be updated within 60 days of any change in required information.
ZS Technologies communicates with the FDA on behalf of the facility to seek the release of detained shipments.
