Food Consultations (FDA Registration & US Agent)

Provides FDA registration and US Agent services for food facilities, including compliance with Bioterrorism Act requirements. Specializes in navigating FDA Industry Systems for submissions and notifications.

Food Consultations offers specialized services for FDA registration and acts as a US Agent for food facilities. They facilitate compliance with critical regulations, including those mandated by the Bioterrorism Act of 2002, ensuring that facilities manufacturing, processing, packing, or holding food products for the U.S. market are properly registered. Their expertise extends to utilizing the FDA Industry Systems (FIS), a 24/7 platform designed for making submissions to the U.S. Food and Drug Administration. This includes managing registrations, listings, and other necessary notifications. The system was developed to enhance information management for food supply protection. Services cover various FDA-related forms and systems, such as FURLS Acidified/Low Acid Canned Foods (LACF), Biologics Export Certification Application & Tracking System (BECATS), Export Listing Module (ELM), and systems for Drug, Medical Device, and Human Cell/Tissue establishments. They assist with forms like 2541/2541d/2541e/2541f/2541g and provide guidance on associated OMB approval numbers and expiration dates.

About

**Who they are**
Food Consultations (FDA Registration & US Agent) is a network of food industry consultants dedicated to enhancing food safety, compliance, and professional support for small food manufacturers and their teams. Founded by Randy Frazer, who brings over 13 years of experience in the food manufacturing industry, the company aims to deliver expert guidance and business solutions.

**Expertise & scope**
* FDA Registration and US Agent services for food facilities, including compliance with Bioterrorism Act requirements.
* Assistance with Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.
* Food label compliance reviews and nutrition analysis, including the creation of compliant nutrition facts panels.
* Guidance on navigating FDA Industry Systems for submissions and notifications.
* Support in obtaining a Unique Facility Identifier (UFI), such as a DUNS number.
* Assistance with updates to facility registrations within 60 days of changes.

**Reputation / proof points**
* Founder Randy Frazer has over 13 years of experience in the food manufacturing industry.
* Services clients across multiple jurisdictions, including the United States, Canada, the United Kingdom, Europe, and the Caribbean.

Additional information

Professional Food Consultation Services specializes in navigating the complexities of the food industry for small manufacturers. They offer comprehensive solutions from production to regulatory compliance. Their services are designed to help businesses understand and seamlessly manage compliance requirements. For foreign food facilities, appointing a US Agent is a prerequisite for FDA registration. This agent must have a physical presence in the United States. Professional Food Consultation Services acts as this agent, managing FDA registration, renewals, and communications between the FDA and the facility. They also assist in obtaining necessary identifiers like the DUNS number for registration.

Key Highlights

  • Specializes in FDA Registration and US Agent services for food facilities. Source
    “As your US Agent, Professional Food Consultation Services will take care of your FDA registration and renewal, and handle any communications between the US FDA and your facility.”
  • Founder Randy Frazer has over 13 years of experience in the food manufacturing industry. Source
    “Randy Frazer is the Founder and Lead Consultant at Professional Food Consultation Services, where he leverages over 13 years of experience in the food manufacturing industry.”
  • Provides assistance with Food Canning Establishment (FCE) registrations and process filings (SID). Source
    “He also assists clients with their Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.”
  • Offers food label compliance reviews and nutrition analysis. Source
    “Additionally, Randy conducts thorough food label compliance reviews and nutrition analysis, ensuring that clients meet all necessary standards and regulations.”

Certifications & Trust Signals

  • Founded by Randy Frazer with over 13 years of experience in food manufacturing. Source
    “Randy Frazer is the Founder and Lead Consultant at Professional Food Consultation Services, where he leverages over 13 years of experience in the food manufacturing industry.”
  • Serves clients across multiple jurisdictions including the United States, Canada, UK, Europe, and the Caribbean. Source
    “His dedication to ensuring food safety and regulatory compliance has positioned him as a trusted advisor for a diverse clientele across multiple jurisdictions, including the United States, Canada, the United Kingdom, Europe, and the Caribbean.”

Buyer Snapshot

Best for
  • Small food manufacturers seeking FDA compliance
  • Foreign food facilities requiring a US Agent
  • Businesses needing assistance with food labeling and nutrition analysis
How engagement typically works
  • Consultative guidance
  • Direct service provision
  • Expert advisory
Typical deliverables
  • FDA Facility Registration
  • US Agent appointment and management
  • FCE-SID filings
  • Food label compliance reports
  • Nutrition facts panels
Good to know
  • Best when requiring specialized FDA regulatory support for food products.

Pricing

Model: Custom pricing
Public range: Publicly listed: $200 - $700
Notes: Pricing varies based on product/package size and specific services like FCE Registration & Process Filings, and FDA Registration.
“Pricing: $350; $350; $350; $650; $200”
HQ: Seattle, US
Languages: English
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
Annual Renewal Support: Yes
Emergency Contact24x7: No
Product Type: food
Service Types: US Agent Services, FDA Registration/Listing Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Export Certificate
Recall Support: No
Inspection Support: No
Annual Renewal Reminder: No

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
Requires appointment of a US Agent for foreign food facilities before FDA registration. Assistance provided for obtaining a DUNS number if needed.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Food facilities
Registration Support
Yes
US Entity State
North Carolina
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