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 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**
* Founded 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 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**
* Founded 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 food facilities through the complexities of FDA regulations. They offer support for foreign food facilities requiring a US Agent, emphasizing the agent's role in communication with the FDA and managing registrations. The company assists in obtaining necessary identifiers like the DUNS number, crucial for accurate facility verification. They also highlight the importance of timely updates to registration information, providing services to ensure compliance with these requirements.
Key Highlights
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Founded by Randy Frazer with over 13 years of food manufacturing industry experience.
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 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).
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.
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, requiring physical presence in the United States.
Source
“The US Agent must be physically present in the United States.”
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Helps obtain Unique Facility Identifiers (UFI) like the 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.”
Buyer Snapshot
Best for
- Small food manufacturers needing FDA registration
- Foreign food facilities requiring a US Agent
- Businesses needing assistance with food label compliance
How engagement typically works
- Consultative guidance
- Direct service provision
Typical deliverables
- FDA Registration support
- US Agent appointment and management
- FCE-SID filings
- Food label compliance reports
- Nutrition facts panel creation
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 service and package size. Some services are listed at $350, $650, $200, and $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 before foreign food facility registration. Assistance provided for obtaining DUNS number and submitting registration updates 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 products
Registration Support
Yes
US Entity State
North Carolina
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