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. Founded by Randy Frazer, who brings over 13 years of experience in the food manufacturing industry, the company aims to help businesses navigate the complexities of the food sector.
**Expertise & scope**
* Specializes in FDA Registration and US Agent services for food manufacturers, particularly those outside the United States.
* Assists with Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.
* Conducts thorough food label compliance reviews and nutrition analysis, including the creation of compliant nutrition facts panels.
* Provides guidance on navigating FDA Industry Systems for submissions and notifications.
* Offers assistance in obtaining a Unique Facility Identifier (UFI), such as a DUNS number.
* Supports updates to facility registrations within 60 days of changes.
**Reputation / proof points**
* Founded by Randy Frazer with over 13 years of experience in the food manufacturing industry.
* Serves a diverse clientele across multiple jurisdictions, including the United States, Canada, the United Kingdom, Europe, and the Caribbean.
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. Founded by Randy Frazer, who brings over 13 years of experience in the food manufacturing industry, the company aims to help businesses navigate the complexities of the food sector.
**Expertise & scope**
* Specializes in FDA Registration and US Agent services for food manufacturers, particularly those outside the United States.
* Assists with Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.
* Conducts thorough food label compliance reviews and nutrition analysis, including the creation of compliant nutrition facts panels.
* Provides guidance on navigating FDA Industry Systems for submissions and notifications.
* Offers assistance in obtaining a Unique Facility Identifier (UFI), such as a DUNS number.
* Supports updates to facility registrations within 60 days of changes.
**Reputation / proof points**
* Founded by Randy Frazer with over 13 years of experience in the food manufacturing industry.
* Serves a diverse clientele across multiple jurisdictions, including the United States, Canada, the United Kingdom, Europe, and the Caribbean.
Additional information
Food Consultations (FDA Registration & US Agent) focuses on simplifying regulatory processes for food facilities. They assist foreign food facilities in appointing a US Agent, who must have a physical presence in the United States. The company handles FDA registration and renewal processes, acting as the communication liaison between the FDA and the facility. They also help clients obtain necessary identifiers like the DUNS number, which is currently recognized by the FDA as a Unique Facility Identifier (UFI) for registration verification. Updates to facility registration information are required within 60 days of any changes, and Food Consultations can manage these submissions.
Key Highlights
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Specializes in FDA Registration and US Agent services for food manufacturers outside the United States.
Source
“His expertise encompasses a wide range of services, including FDA Registration and US Agent Service for food manufacturers outside the United States.”
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Assists with Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.
Source
“He also assists clients with their Food Canning Establishment (FCE) registrations and process filings (SID) for acidified and low-acid canned foods.”
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Provides comprehensive 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.”
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Offers assistance in obtaining a Unique Facility Identifier (UFI), such as a DUNS number.
Source
“If you do not have a DUNS number for your food facility, Professional Food Consultation Services will help you to obtain one.”
Certifications & Trust Signals
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Founded by Randy Frazer with 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.”
Buyer Snapshot
Best for
- Foreign food facilities requiring FDA registration and a US Agent.
- Small food manufacturers seeking compliance guidance.
- Businesses needing assistance with FCE registrations and SID filings.
How engagement typically works
- Direct consultation and service provision.
- Assistance with regulatory submissions and communications.
Typical deliverables
- FDA Establishment Registration
- US Agent appointment and management
- FCE-SID filings
- Food label compliance review
- DUNS number acquisition support
Good to know
- Best when requiring specific FDA regulatory support for food facilities.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $200 - $700
Notes:
Pricing varies per product/package size and service. FCE Registration & Process Filings start at $350. FDA Registration and US Agent services are listed at $700.
“Pricing: $350; $350; $350; $650; $200”
HQ:
Seattle, US
Languages:
English
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
Annual Renewal Support:
Yes
Emergency Contact24x7:
Yes
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
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 with a place of business or residence in the US. Assistance provided in obtaining UFI (DUNS number). Updates to registration required within 60 days of changes.
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
