Magneco LLC
Magneco LLC offers comprehensive FDA regulatory consulting and support for food and beverage exporters. They specialize in FDA registration, U.S. Agent services, FSVP compliance, and labeling.
Magneco LLC is a dedicated provider of regulatory consulting and support for industries regulated by the FDA, USDA, and other federal and state agencies. They assist food exporters worldwide in meeting tailored solutions to comply with FDA regulations. Their core services include FDA Registration, FCE-SID Registration, acting as the FDA U.S. Agent, DUNS – UFI Number acquisition, FDA FSVP (Foreign Suppliers Verification Programs), Food Safety Plan development, FSVP Agent services, FDA Labeling compliance, and Recall Plan creation. Magneco LLC focuses on providing solid solutions for food and beverage imports/exports, creating unique plans based on client needs. Their team of food scientists is ready to help ensure your products meet all necessary U.S. safety and labeling standards, facilitating smooth entry into the U.S. market.
About
**Who they are**
Magneco LLC is a regulatory consulting firm specializing in FDA compliance for food and beverage exporters. They offer comprehensive support for navigating U.S. Food and Drug Administration regulations.
**Expertise & scope**
* FDA U.S. Agent services, acting as the primary communication link between foreign food facilities and the FDA for routine and emergency communications.
* FDA Registration support, including Food Facility Registration (FFR) and Food Canning Establishment (FCE) registration.
* Foreign Supplier Verification Programs (FSVP) compliance assistance for importers.
* FDA Labeling guidance to ensure products meet U.S. market requirements.
* FCE-SID Registration for acidified and low-acid canned food processors.
* Assistance in obtaining a Unique Facility Identifier (UFI) such as the DUNS number.
* Food Safety Plan (HARPC) development, including hazard analysis and preventive controls.
**Reputation / proof points**
* Specializes in services mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Food Safety Modernization Act (FSMA).
Magneco LLC is a regulatory consulting firm specializing in FDA compliance for food and beverage exporters. They offer comprehensive support for navigating U.S. Food and Drug Administration regulations.
**Expertise & scope**
* FDA U.S. Agent services, acting as the primary communication link between foreign food facilities and the FDA for routine and emergency communications.
* FDA Registration support, including Food Facility Registration (FFR) and Food Canning Establishment (FCE) registration.
* Foreign Supplier Verification Programs (FSVP) compliance assistance for importers.
* FDA Labeling guidance to ensure products meet U.S. market requirements.
* FCE-SID Registration for acidified and low-acid canned food processors.
* Assistance in obtaining a Unique Facility Identifier (UFI) such as the DUNS number.
* Food Safety Plan (HARPC) development, including hazard analysis and preventive controls.
**Reputation / proof points**
* Specializes in services mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Food Safety Modernization Act (FSMA).
Additional information
Magneco LLC emphasizes its role as a crucial communication channel for foreign food facilities with the FDA, particularly for emergency situations. They highlight that representations made by their U.S. Agent are considered equivalent to those made by the foreign facility itself. For FSVP compliance, they assist both importers and foreign establishments, underscoring the importance of a designated U.S. entity to take responsibility for FSVP requirements. Their services are designed to help exporters meet the stringent safety and labeling standards required for the U.S. market.
Key Highlights
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Provides FDA U.S. Agent services, acting as the primary communication link for foreign food facilities with the FDA.
Source
“The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.”
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Offers comprehensive support for FDA Registration, including Food Facility Registration (FFR) and FCE-SID Registration for specific food types.
Source
“Facilities that manufacture, process, or package foods intended for consumption in the United States are required to register in the FDA Food Facility Registration (FFR) system.”
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Assists with Foreign Supplier Verification Programs (FSVP) compliance for food importers and foreign establishments.
Source
“The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.”
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Helps obtain a Unique Facility Identifier (UFI), such as the DUNS number, required for FDA facility registration.
Source
“Under 21 CFR 1.232(a)(2), domestic and foreign facilities must submit a unique facility identifier (UFI) recognized as acceptable to FDA in the facility’s registration.”
Certifications & Trust Signals
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Assists with compliance requirements stemming from the Bioterrorism Act of 2002.
Source
“The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA)...”
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Supports compliance with the Food Safety Modernization Act (FSMA) and its Preventive Controls Rule (HARPC).
Source
“This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls...”
Buyer Snapshot
Best for
- Foreign food facilities needing a U.S. Agent
- Exporters requiring FDA registration
- Companies needing FSVP compliance support
How engagement typically works
- Consultative support for regulatory requirements
- Assistance with documentation and filings
- Acting as a designated U.S. representative
Typical deliverables
- FDA U.S. Agent designation
- Completed FDA registrations (FFR, FCE-SID)
- FSVP compliance strategy
- Labeling compliance review
- DUNS number acquisition
Good to know
- Best when engaging with FDA regulations for food and beverage products.
- Requires clear information from the foreign facility to complete filings.
HQ:
Houston, US
Languages:
English, Spanish
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Beverages
Portfolio:
1-5
Onboarding time:
1–10 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Registration Support:
Yes
Emergency Contact24x7:
Yes
Product Type:
drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Recall Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Export Certificate, Regulatory Consulting
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Contact for quote, fill out form, send to email.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Food and beverage products
Registration Support
Yes, FDA establishment registration (FFR) and FCE-SID registration.
Emergency Contact24x7
Implied through U.S. Agent role, but not explicitly stated as 24/7.
Recall Support
Yes, mentioned as a service ('Recall Plan').
US Entity State
United States
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