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 (Bioterrorism Act compliance)
* FDA U.S. Agent services, acting as the primary communication link with the FDA for foreign food facilities.
* Foreign Supplier Verification Programs (FSVP) compliance assistance for importers and foreign establishments.
* FDA Labeling support to ensure compliance with U.S. food labeling regulations.
* FCE-SID Registration for commercial processors of acidified and low-acid canned foods.
* Assistance in obtaining a Unique Facility Identifier (UFI) such as a DUNS number.
* Food Safety Plan (HARPC) development, including hazard analysis and preventive controls.

**Reputation / proof points**
* Offers services in English, Spanish, Greek, and Italian.

Additional information

Magneco LLC assists foreign food facilities in meeting U.S. FDA regulatory requirements. Their services are crucial for exporters and importers to ensure their products comply with U.S. safety standards. They facilitate communication with the FDA, manage registration processes, and provide guidance on complex regulations like FSVP and labeling. Engaging Magneco can streamline the compliance process, helping businesses avoid strict regulatory actions and ensure market access for their food products in the United States.

Key Highlights

  • Specializes in FDA registration, U.S. Agent services, FSVP compliance, and labeling for food and beverage exporters. Source
    “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.”
  • Acts as the U.S. Agent, serving as the primary communication link between foreign food facilities and the U.S. FDA for routine and emergency communications. 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.”
  • Provides assistance with Foreign Supplier Verification Programs (FSVP) for importers and foreign establishments to meet U.S. safety standards. Source
    “MAGNECO offers complete assistance to FSVP importers and/or foreign establishments willing to conform with FSVP rule”
  • Assists in obtaining 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

  • Offers services in multiple languages including English, Spanish, Greek, and Italian. Source
    “English Ελληνικά Italiano Español”

Buyer Snapshot

Best for
  • Foreign food facilities needing FDA registration
  • Exporters requiring a U.S. Agent
  • Importers needing FSVP compliance support
How engagement typically works
  • Consultative support
  • Registration assistance
  • Compliance guidance
Typical deliverables
  • FDA Registration documentation
  • U.S. Agent designation
  • FSVP compliance plans
  • Labeling compliance review
  • FCE-SID registration filings
  • DUNS number acquisition support
Good to know
  • Best when engaging with FDA regulations for food and beverage products.
HQ: Houston, US
Languages: English, Spanish
Timezones: America/New_York, America/Chicago, America/Denver, America/Los_Angeles
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: food
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 after filling out a form or via email/phone.
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
Emergency Contact24x7
The U.S. Agent acts as a communication link for both routine and emergency communications.
Recall Support
Yes, Recall Plan is listed as a service
US Entity State
United States
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