FDA Specialist
★★★★★
5.0
/ 5
•
17 reviews
FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs. Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning. Led by Richard Chiang, Owner and Chief Consultant.
FDA Specialist offers comprehensive services to navigate the complex landscape of FDA regulations. With extensive experience, including a former FDA specialist with 13 years of service, they provide expert guidance on food facility registration, medical device requirements, cosmetic regulations under MoCRA, and the FDA drug approval process. They are particularly adept at assisting foreign facilities by acting as a US agent, facilitating communication with the FDA, and helping to schedule inspections. Their services extend to ensuring compliance with various import regulations, including Foreign Supplier Verification Program (FSVP) for food, and Prior Notice submissions. For medical devices, they clarify regulatory classifications and assist with establishment registration and premarket notifications. For cosmetics, they address facility registration and product listing requirements. For drugs, they guide through establishment registration, drug listing, and adherence to Good Manufacturing Practices (GMPs). FDA Specialist is committed to helping businesses understand and meet FDA requirements, ensuring smooth market entry and ongoing compliance. They offer free consultations to discuss specific needs and provide tailored solutions for businesses dealing with FDA-regulated products.
About
**Who they are**
FDA Specialist is a consulting firm providing comprehensive FDA regulatory compliance services. They focus on ensuring products meet U.S. food, dietary supplement, cosmetic, medical device, and drug requirements.
**Expertise & scope**
* **Food Compliance:** Facility registration, US Agent services for foreign facilities, Foreign Supplier Verification Program (FSVP), Low-acid canned Food (LACF) and Acidified Food compliance, Prior Notice, label requirements, and ingredient checks.
* **Medical Device Compliance:** Assistance with regulatory classification (Class I, II, III), establishment registration, US Agent services, device listing, Premarket Notification (510k), and Premarket Approval.
* **Cosmetic Compliance:** Guidance on Modernization of Cosmetics Regulation Act (MoCRA) requirements, cosmetic facility registration, product listing, ingredient and product safety, and labeling.
* **Drug Compliance:** Support for establishment registration, drug listing (including NDC assignment), Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) drugs.
* **Import Support:** Services related to FDA Import Alerts, including understanding Red and Green Lists, petitioning for removal from Red Lists, and resolving import detentions. They also assist with import detention and release guidance, providing evidence of compliance and reconditioning options.
**Reputation / proof points**
* Led by Richard Chiang, Owner and Chief Consultant.
* Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning.
FDA Specialist is a consulting firm providing comprehensive FDA regulatory compliance services. They focus on ensuring products meet U.S. food, dietary supplement, cosmetic, medical device, and drug requirements.
**Expertise & scope**
* **Food Compliance:** Facility registration, US Agent services for foreign facilities, Foreign Supplier Verification Program (FSVP), Low-acid canned Food (LACF) and Acidified Food compliance, Prior Notice, label requirements, and ingredient checks.
* **Medical Device Compliance:** Assistance with regulatory classification (Class I, II, III), establishment registration, US Agent services, device listing, Premarket Notification (510k), and Premarket Approval.
* **Cosmetic Compliance:** Guidance on Modernization of Cosmetics Regulation Act (MoCRA) requirements, cosmetic facility registration, product listing, ingredient and product safety, and labeling.
* **Drug Compliance:** Support for establishment registration, drug listing (including NDC assignment), Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) drugs.
* **Import Support:** Services related to FDA Import Alerts, including understanding Red and Green Lists, petitioning for removal from Red Lists, and resolving import detentions. They also assist with import detention and release guidance, providing evidence of compliance and reconditioning options.
**Reputation / proof points**
* Led by Richard Chiang, Owner and Chief Consultant.
* Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning.
Additional information
FDA Specialist assists foreign facilities by providing a US Agent, a requirement for companies marketing food products in the US. This agent acts as a communication channel with the FDA and aids in scheduling inspections. For imported products facing detention, they offer guidance on overcoming violations by providing evidence of compliance, such as private lab reports, or by reconditioning the product. They also help companies navigate the process of petitioning to be removed from FDA Import Alert 'Red Lists' by demonstrating corrective actions and presenting evidence of compliant shipments.
Key Highlights
-
Provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs.
Source
“FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs.”
-
Offers US Agent services for foreign facilities, a requirement for marketing food products in the US.
Source
“A registered facility in a foreign country must have a US agent. The US agent must be located in the US and receive communications from FDA...”
-
Assists with resolving import detentions and navigating FDA Import Alerts, including petitioning for removal from 'Red Lists'.
Source
“For a company to have its products removed from the Red List of an Import Alert, the company must submit a petition to FDA, detailing how the company has identified the source of the problem...”
-
Expertise covers Foreign Supplier Verification Program (FSVP) compliance for food importers.
Source
“FDA is now enforcing the FSVP rule which requires food importers to maintain documentation and records verifying that the foods they import meet US food-safety standards.”
Certifications & Trust Signals
-
Led by Richard Chiang, Owner and Chief Consultant.
Source
“Led by Richard Chiang, Owner and Chief Consultant.”
Buyer Snapshot
Best for
- Foreign manufacturers and suppliers needing a US Agent.
- Companies facing FDA import detentions or import alerts.
- Businesses seeking to ensure compliance with FDA regulations for food, drugs, medical devices, and cosmetics.
How engagement typically works
- Consultative approach to regulatory challenges.
- Focus on practical solutions and evidence-based compliance.
Typical deliverables
- US Agent services.
- Regulatory compliance strategies.
- Documentation and petition support for import issues.
- Guidance on facility registration and product listing.
Good to know
- Best when requiring specific FDA regulatory expertise for market entry or compliance issues.
HQ:
Long Beach, 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
Service Types:
US Agent Services, Food Facility Registration, US Agent Services (Food, Cosmetics, Medical Devices, Drugs), DUNS Application, Label Review (Food, Cosmetics, Medical Devices, Drugs), FSVP (Foreign Supplier Verification Program), APHIS VS Permit Application, Food Canning Establishment (FCE) and SID Filing, Cosmetic Facility Registration, Cosmetic Product Listing, Medical Device Establishment Registration, Device Listing, 510(k) Application Support, Regulatory Evaluation, Drug Establishment Registration, Drug Listing (NDC), Import Hold/Detention Resolution, Import Alert Petitioning, Regulatory Starter Blueprint, FDA Registration/Listing Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Import Alert/Detention Resolution
Specialties:
Foods and Dietary Supplements, Cosmetics, Medical Devices, Drugs
Pricing:
food: [object Object] • cosmetics: [object Object] • medicalDevices: [object Object] • drugs: [object Object] • general: [object Object]
Turnaround Times:
foodFacilityRegistration: 5 business days • dunsApplication: 5 business days (submission), D&B may take 5+ business days • labelReview: 10 business days (up to 5 labels) • fsvp: Generally 4 weeks • cosmeticRegistration: 5 business days • cosmeticListing: Varies by volume • cosmeticLabelReview: 10 business days (up to 20 labels) • medicalDeviceRegistration: 5 business days
Notes:
All label review services include one re-review after changes at no additional charge. If FDA objects to a label after service (e.g., detention), FDASpecialist will represent client before FDA for no additional charge if all recommended changes were made and product not on Import Alert. Contact info@fdaspecialist.com for RFQs. Owner: Richard Chiang (richard@fdaspecialist.com, 562-882-4981).
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 understanding of product classification, facility details, and relevant regulatory requirements for specific services like registration or listing.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Foods, Dietary Supplements, Cosmetics, Medical Devices, Drugs
Registration Support
Yes, for food facilities, drug establishments, and cosmetic facilities.
Inspection Support
Yes, US Agent assists FDA with scheduling inspections of foreign facilities.
US Entity State
US
Recall Support
No explicit mention of recall support.
Emergency Contact24x7
No explicit mention of 24/7 emergency contact.
