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. They aim to help food businesses navigate industry complexities from production to regulatory compliance.
**Expertise & scope**
* FDA Registration and US Agent services for food manufacturers, particularly those outside the United States.
* 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 the FDA's Bioterrorism Act requirements and using FDA Industry Systems for submissions.
* Support in obtaining a Unique Facility Identifier (UFI), such as a DUNS number, for FDA registration.
* Assistance with updating facility registrations within 60 days of changes to required information.
**Reputation / proof points**
* Founded and led by Randy Frazer, who has 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. They aim to help food businesses navigate industry complexities from production to regulatory compliance.
**Expertise & scope**
* FDA Registration and US Agent services for food manufacturers, particularly those outside the United States.
* 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 the FDA's Bioterrorism Act requirements and using FDA Industry Systems for submissions.
* Support in obtaining a Unique Facility Identifier (UFI), such as a DUNS number, for FDA registration.
* Assistance with updating facility registrations within 60 days of changes to required information.
**Reputation / proof points**
* Founded and led by Randy Frazer, who has 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
Professional Food Consultation Services specializes in guiding foreign food facilities through the FDA registration process. They emphasize the mandatory requirement for a US Agent, who must have a physical presence in the United States. As your appointed US Agent, they manage FDA registration, renewals, and all communications between the FDA and your facility. They also assist in obtaining the necessary Unique Facility Identifier (UFI), such as a DUNS number, which is crucial for accurate registration. Updates to facility registration information must be submitted within 60 days of any changes, a process they can facilitate.
Key Highlights
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Founded and led 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.”
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Provides FDA registration and US Agent services for food facilities 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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Offers food label compliance reviews and nutrition analysis, including creating compliant nutrition facts panels.
Source
“Additionally, Randy conducts thorough food label compliance reviews and nutrition analysis, ensuring that clients meet all necessary standards and regulations.”
Certifications & Trust Signals
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Acts as a US Agent, managing FDA registration, renewals, and communications.
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.”
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Helps obtain Unique Facility Identifiers (UFI) such as DUNS numbers for FDA registration.
Source
“If you do not have a DUNS number for your food facility, Professional Food Consultation Services will help you to obtain one.”
Buyer Snapshot
Best for
- Foreign food facilities seeking FDA registration
- Companies needing a US Agent
- Small food manufacturers requiring compliance support
How engagement typically works
- Consultative guidance
- Direct service provision
- Information and submission assistance
Typical deliverables
- FDA Registration
- US Agent appointment and management
- FCE-SID filings
- Food label compliance reports
- Nutrition facts panel creation
Good to know
- Best when requiring assistance with US FDA regulations for food facilities.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $200 - $700 for specific services
Notes:
Pricing is listed per product/package size for certain services, with additional package sizes at half price. Specific service prices range from $200 to $700.
“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
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:
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. Assistance provided in obtaining a Unique Facility Identifier (UFI) like a DUNS number. Updates to registration information must be submitted 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
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