FDA Imports
United States Food and Drug Administration
Regulatory & legal consulting firm with over 100 years of direct FDA experience, specializing in FDA-regulated imports: U.S. Agent services, import alerts & refusals, facility registration, customs & border enforcement, labeling & claims review, and legal defense.
FDAImports.com is a compliance expert with over 100 years of direct FDA experience, specializing in helping companies of all sizes navigate U.S. regulatory requirements for highly-regulated commodities. Their regulatory specialists and affiliated attorneys represent proven consulting and legal experience, integrated into a single source for solving the problems involved in bringing products to the highly-regulated United States market. They efficiently handle highly complex technical, regulatory, and legal issues and provide individual solutions for businesses around the world.
About
FDAImports.com is a compliance expert with over 100 years of direct FDA experience, specializing in helping companies of all sizes navigate U.S. regulatory requirements for highly-regulated commodities. Their regulatory specialists and affiliated attorneys represent proven consulting and legal experience, integrated into a single source for solving the problems involved in bringing products to the highly-regulated United States market.
**Who They Are:**
FDAImports.com is a compliance expert with over 100 years of direct FDA experience, specializing in helping companies of all sizes navigate U.S. regulatory requirements for highly-regulated commodities.
**Expertise & Scope:**
* Assistance with U.S. regulatory requirements for highly-regulated commodities.
* Expertise in product label reviews to ensure compliance with FDA, FTC, CBP, and other agency expectations.
* Support for facility registration and listing with the FDA for food, medical device, cosmetics and drug facilities.
* Guidance on claims substantiation, ensuring product claims are truthful, not misleading, and scientifically supported.
* Services to help firms get removed from FDA Import Alerts and/or obtain FDA Import Alert Green Ticket.
* Assistance with FDA holds and detentions.
* Development of Standard Operating Procedures (SOPs) and Quality Controls.
**Reputation / Proof Points:**
* Extensive experience in handling highly-regulated commodities.
* Team possesses over 100 years of direct FDA experience.
**Additional Services:**
FDAImports.com provides comprehensive services for companies importing FDA-regulated products into the United States, including U.S. Agent designation, facility registration, handling import alerts & refusals, customs & border enforcement issues, labeling & claims review, and legal defense. They help companies navigate the complex regulatory landscape for foods, drugs, medical devices, cosmetics, and other FDA-regulated products.
**Who They Are:**
FDAImports.com is a compliance expert with over 100 years of direct FDA experience, specializing in helping companies of all sizes navigate U.S. regulatory requirements for highly-regulated commodities.
**Expertise & Scope:**
* Assistance with U.S. regulatory requirements for highly-regulated commodities.
* Expertise in product label reviews to ensure compliance with FDA, FTC, CBP, and other agency expectations.
* Support for facility registration and listing with the FDA for food, medical device, cosmetics and drug facilities.
* Guidance on claims substantiation, ensuring product claims are truthful, not misleading, and scientifically supported.
* Services to help firms get removed from FDA Import Alerts and/or obtain FDA Import Alert Green Ticket.
* Assistance with FDA holds and detentions.
* Development of Standard Operating Procedures (SOPs) and Quality Controls.
**Reputation / Proof Points:**
* Extensive experience in handling highly-regulated commodities.
* Team possesses over 100 years of direct FDA experience.
**Additional Services:**
FDAImports.com provides comprehensive services for companies importing FDA-regulated products into the United States, including U.S. Agent designation, facility registration, handling import alerts & refusals, customs & border enforcement issues, labeling & claims review, and legal defense. They help companies navigate the complex regulatory landscape for foods, drugs, medical devices, cosmetics, and other FDA-regulated products.
Additional information
FDA Imports emphasizes the critical nature of accurate product labeling and facility registration for market access. They highlight that a significant percentage of product rejections stem from improper labeling, involving multiple government agencies. For foreign manufacturers, designating a verified U.S. Agent is a mandatory step for FDA registration, with the agent facilitating communication and potentially sharing responsibility for certain fees. The firm's services extend to helping companies understand and meet the specific requirements for different product categories, such as dietary supplements, OTC drugs, and medical devices, ensuring compliance from initial registration through to market entry.
Key Highlights
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Over 100 years of direct FDA experience across the team
Source
“FDAImports.com is a compliance expert with over 100 years of direct FDA experience”
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Product label reviews for FDA, FTC, CBP, and other agency compliance
Source
“Expertise in product label reviews to ensure compliance with FDA, FTC, CBP, and other agency expectations”
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Facility registration and listing support for food, medical device, cosmetics, and drug facilities
Source
“Support for facility registration and listing with the FDA for food, medical device, cosmetics and drug facilities”
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Import Alert removal and Green Ticket services
Source
“Services to help firms get removed from FDA Import Alerts and/or obtain FDA Import Alert Green Ticket”
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FDA holds and detentions assistance
Source
“Assistance with FDA holds and detentions”
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SOPs and Quality Controls development
Source
“Development of Standard Operating Procedures (SOPs) and Quality Controls”
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Claims substantiation guidance
Source
“Guidance on claims substantiation, ensuring product claims are truthful, not misleading, and scientifically supported”
Certifications & Trust Signals
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Over 100 years of direct FDA experience across the team
Source
“FDAImports.com is a compliance expert with over 100 years of direct FDA experience”
-
Extensive experience in handling highly-regulated commodities
Source
“Extensive experience in handling highly-regulated commodities”
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Founded by a former FDA official
Source
“Founded by a former FDA official”
Buyer Snapshot
Best for
- Foreign manufacturers needing a U.S. Agent
- Companies facing import alerts or detentions
- Businesses requiring FDA facility registration
- Firms needing label and claims compliance review
How engagement typically works
- Consultative approach to regulatory challenges
- Expert analysis and guidance
- Facilitation of FDA submissions and communications
Typical deliverables
- U.S. Agent designation and support
- Completed FDA facility registrations/listings
- Label compliance reports
- Claims substantiation analysis reports
- Strategies for import alert removal
Good to know
- Best when requiring specialized FDA regulatory expertise for imports.
- Requires clear product information and business structure details for accurate guidance.
HQ:
Los Angeles, US
Languages:
English
Timezones:
America/New_York
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Drugs, Medical devices
Portfolio:
6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,400
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Annual Renewal Support:
No
Registration Support:
No
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, Product/Device Listing, Import Alert/Detention Resolution, Regulatory Consulting
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