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 focus on providing essential services to ensure foreign food facilities meet U.S. regulatory requirements.
**Expertise & scope**
* FDA U.S. Agent services, acting as the primary communication link between foreign food facilities and the U.S. FDA for both routine and emergency communications, as mandated by 21 CFR 1.227.
* FDA Registration support, including Food Facility Registration (FFR) and Food Canning Establishment (FCE) Registration & Process Filings (SID) for acidified and low-acid canned foods.
* Foreign Supplier Verification Programs (FSVP) assistance for importers to verify that imported food meets U.S. safety standards.
* FDA Labeling compliance, ensuring food products marketed in the U.S. adhere to regulations under the FD&C Act and Fair Packaging and Labeling Act.
* Food Safety Plan (HARPC) development, including hazard analysis and risk-based preventive controls as required by the FDA Food Safety Modernization Act (FSMA).
* Assistance with obtaining a Unique Facility Identifier (UFI), specifically the DUNS number, required for facility registration under 21 CFR 1.232(a)(2).
**Reputation / proof points**
* Offers services in English and Spanish.
Magneco LLC is a regulatory consulting firm specializing in FDA compliance for food and beverage exporters. They focus on providing essential services to ensure foreign food facilities meet U.S. regulatory requirements.
**Expertise & scope**
* FDA U.S. Agent services, acting as the primary communication link between foreign food facilities and the U.S. FDA for both routine and emergency communications, as mandated by 21 CFR 1.227.
* FDA Registration support, including Food Facility Registration (FFR) and Food Canning Establishment (FCE) Registration & Process Filings (SID) for acidified and low-acid canned foods.
* Foreign Supplier Verification Programs (FSVP) assistance for importers to verify that imported food meets U.S. safety standards.
* FDA Labeling compliance, ensuring food products marketed in the U.S. adhere to regulations under the FD&C Act and Fair Packaging and Labeling Act.
* Food Safety Plan (HARPC) development, including hazard analysis and risk-based preventive controls as required by the FDA Food Safety Modernization Act (FSMA).
* Assistance with obtaining a Unique Facility Identifier (UFI), specifically the DUNS number, required for facility registration under 21 CFR 1.232(a)(2).
**Reputation / proof points**
* Offers services in English and Spanish.
Additional information
Magneco LLC emphasizes its role as a crucial communication channel for foreign food facilities with the U.S. FDA. They highlight that the U.S. Agent is the designated point of contact for all FDA communications, including emergencies, unless an alternative contact is specified. Their services are designed to navigate complex FDA regulations, ensuring that importers and foreign suppliers can meet requirements for food safety, registration, and labeling. Engaging Magneco LLC can streamline the process of establishing compliance for businesses exporting food products to the United States.
Key Highlights
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Provides FDA U.S. Agent services, acting as the primary communication link for foreign food facilities with the U.S. 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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Assists with FDA Food Facility Registration (FFR) and FCE-SID Registration for acidified and low-acid canned foods.
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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Offers support for Foreign Supplier Verification Programs (FSVP) compliance for food importers.
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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Provides guidance on FDA food labeling requirements to ensure compliance with U.S. regulations.
Source
“Food labeling is one of the important regulatory requirements for food products marketed in the United States.”
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Facilitates the acquisition of the DUNS number, a required Unique Facility Identifier (UFI) for FDA 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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Offers services in English and Spanish to cater to a diverse client base.
Source
“English Ελληνικά Italiano Español”
Buyer Snapshot
Best for
- Foreign food facilities needing an FDA U.S. Agent
- Exporters requiring FDA registration and compliance support
- Companies needing assistance with FSVP and labeling regulations
How engagement typically works
- Consultative support for regulatory requirements
- Assistance with documentation and filings
- Communication facilitation with FDA
Typical deliverables
- Designated U.S. Agent services
- Completed FDA registrations (FFR, FCE-SID)
- FSVP compliance strategy and support
- Labeling compliance guidance
- Food Safety Plan (HARPC) development
- DUNS number acquisition support
Good to know
- Best when engaging for FDA compliance for food and beverage products.
- Requires clear information from the foreign facility to facilitate registration and compliance.
HQ:
Houston, US
Languages:
English, Spanish
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
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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 a quote, fill out a form, and submit to a designated email address.
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 as part of U.S. Agent role, but not explicitly stated as 24/7.
Recall Support
Yes, as part of Food Safety Plan (HARPC) and general FDA compliance.
US Entity State
United States
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