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 provides FDA regulatory consulting and support for food and beverage exporters. They specialize in FDA registration, U.S. Agent services, FSVP compliance, and labeling.
**Expertise & scope**
* FDA Registration: Assistance with the FDA Food Facility Registration (FFR) system and Food Canning Establishment (FCE) registration for acidified and low-acid canned foods.
* FDA U.S. Agent: Acts as the domestic representative for foreign food facilities, facilitating all communication with the FDA, including routine and emergency communications.
* FSVP Compliance: Support for importers to meet Foreign Suppliers Verification Programs requirements, including risk-based supplier verification activities.
* FDA Labeling: Guidance on meeting FDA food labeling regulations, including nutrition labeling requirements.
* DUNS – UFI Number: Assistance in obtaining a Unique Facility Identifier (UFI), specifically the DUNS number, required for facility registration.
* Food Safety Plan (HARPC): Development and implementation of food safety plans that include hazard analysis and risk-based preventive controls as mandated by FSMA.
**Reputation / proof points**
* Offers services in English, Spanish, Greek, and Italian.
Magneco LLC provides FDA regulatory consulting and support for food and beverage exporters. They specialize in FDA registration, U.S. Agent services, FSVP compliance, and labeling.
**Expertise & scope**
* FDA Registration: Assistance with the FDA Food Facility Registration (FFR) system and Food Canning Establishment (FCE) registration for acidified and low-acid canned foods.
* FDA U.S. Agent: Acts as the domestic representative for foreign food facilities, facilitating all communication with the FDA, including routine and emergency communications.
* FSVP Compliance: Support for importers to meet Foreign Suppliers Verification Programs requirements, including risk-based supplier verification activities.
* FDA Labeling: Guidance on meeting FDA food labeling regulations, including nutrition labeling requirements.
* DUNS – UFI Number: Assistance in obtaining a Unique Facility Identifier (UFI), specifically the DUNS number, required for facility registration.
* Food Safety Plan (HARPC): Development and implementation of food safety plans that include hazard analysis and risk-based preventive controls as mandated by FSMA.
**Reputation / proof points**
* Offers services in English, Spanish, Greek, and Italian.
Additional information
Magneco LLC emphasizes its role as a crucial communication link between foreign food facilities and the U.S. FDA, particularly for U.S. Agent services. They clarify that the U.S. Agent is responsible for all FDA communications, including emergencies, unless a different contact is designated. For FSVP compliance, they assist both importers and foreign establishments, highlighting the importer's responsibility for verification activities. The company also aids in obtaining the DUNS number, a required Unique Facility Identifier (UFI) for FDA registration, noting that this service is free of charge and they will assist during the registration process.
Key Highlights
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Magneco LLC specializes in FDA U.S. Agent services, acting as the primary communication link between foreign food facilities and 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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Provides comprehensive support for FSVP compliance, assisting importers in meeting U.S. safety standards for imported food.
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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Assists in obtaining the DUNS number, a required Unique Facility Identifier (UFI) for FDA registration, at no charge.
Source
“No, issue of DUNS number is free of charge for FDA registration purposes. MAGNECO LLC will assist your company obtain the DUNS number during registration.”
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Offers support for FCE-SID registration for facilities producing acidified and low-acid canned foods.
Source
“Federal Regulations require commercial processors of shelf stable acidified foods and low-acid canned foods in a hermetically sealed container to be sold in the United States to register each establishment and file scheduled processes with the Food and Drug Administration for each product, product style, container size and type and processing method (21 CFR 108).”
Certifications & Trust Signals
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Provides services in multiple languages including English and Spanish.
Source
“English Ελληνικά Italiano Español”
Buyer Snapshot
Best for
- Foreign food facilities needing a U.S. Agent
- Exporters requiring FDA registration and compliance support
- Companies needing assistance with FSVP and food labeling regulations
How engagement typically works
- Consultative support for regulatory requirements
- Assistance with documentation and registration processes
- Facilitation of communication with FDA
Typical deliverables
- FDA U.S. Agent designation
- Completed FDA facility registrations
- FSVP compliance plans
- Guidance on FDA labeling requirements
- DUNS number acquisition support
Good to know
- Best when engaging with food and beverage exporters.
- Requires clear communication from the foreign facility.
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 register@magneco.us
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
Emergency Contact24x7
Yes, as part of U.S. Agent services
Recall Support
Yes
US Entity State
United States
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