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 provides comprehensive FDA regulatory compliance services, focusing on acting as a U.S. Agent for foreign facilities. Led by Owner and Chief Consultant Richard Chiang, the firm assists businesses in navigating complex FDA requirements.
**Expertise & scope**
* **Food Products:** Facility registration, U.S. Agent services, Foreign Supplier Verification Program (FSVP) compliance, label reviews, and assistance with import holds/detentions and import alert petitioning.
* **Medical Devices:** Guidance on regulatory classification (Class I, II, III), establishment registration, device listing, premarket notification (510k), and premarket approval processes.
* **Cosmetics:** Support with cosmetic facility registration, product listing, ingredient and product safety, and compliance with new requirements under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drugs:** Assistance with establishment registration, drug listing, Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Compliance:** Expertise in understanding and resolving FDA import alerts, detentions, and refusals, including strategies for getting products off the "Red List" and navigating "detention without physical exam" (DWPE).
**Reputation / proof points**
* Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning.
FDA Specialist provides comprehensive FDA regulatory compliance services, focusing on acting as a U.S. Agent for foreign facilities. Led by Owner and Chief Consultant Richard Chiang, the firm assists businesses in navigating complex FDA requirements.
**Expertise & scope**
* **Food Products:** Facility registration, U.S. Agent services, Foreign Supplier Verification Program (FSVP) compliance, label reviews, and assistance with import holds/detentions and import alert petitioning.
* **Medical Devices:** Guidance on regulatory classification (Class I, II, III), establishment registration, device listing, premarket notification (510k), and premarket approval processes.
* **Cosmetics:** Support with cosmetic facility registration, product listing, ingredient and product safety, and compliance with new requirements under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drugs:** Assistance with establishment registration, drug listing, Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Compliance:** Expertise in understanding and resolving FDA import alerts, detentions, and refusals, including strategies for getting products off the "Red List" and navigating "detention without physical exam" (DWPE).
**Reputation / proof points**
* 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 emphasizes proactive compliance to avoid regulatory actions such as import detentions and import alerts. For food importers, understanding and implementing the Foreign Supplier Verification Program (FSVP) is crucial, requiring qualified individuals to assess hazards and risks for each imported food. For medical devices, correctly classifying the device (Class I, II, or III) is a foundational step in meeting FDA requirements. Companies dealing with FDA import alerts should be aware that products can be placed on a "Red List" and detained without physical examination, necessitating a petition to FDA with corrective actions and evidence of compliance, often demonstrated through consecutive "clean shipments."
Key Highlights
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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.”
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Offers U.S. Agent services for foreign facilities, facilitating communication with the FDA.
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...”
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Assists with Foreign Supplier Verification Program (FSVP) compliance for imported foods.
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.”
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Specializes in resolving FDA import alerts and detentions, 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...”
Certifications & Trust Signals
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Led by Richard Chiang, Owner and Chief Consultant.
Source
“Led by Richard Chiang, Owner and Chief Consultant.”
Buyer Snapshot
Best for
- Foreign companies seeking a U.S. Agent for FDA compliance.
- Businesses needing assistance with FDA registration and listing requirements.
- Companies facing import detentions or import alerts.
- Manufacturers and importers of food, medical devices, cosmetics, and drugs.
How engagement typically works
- Consultative approach to regulatory challenges.
- Focus on practical solutions and compliance strategies.
- Direct assistance with FDA submissions and communications.
Typical deliverables
- FDA U.S. Agent representation.
- Facility registration and product listing support.
- FSVP documentation and compliance plans.
- Guidance on import alert resolution and detention response.
Good to know
- Best when requiring specialized FDA regulatory expertise for imported goods.
- Ideal for companies unfamiliar with U.S. FDA regulations.
Pricing
Model:
Custom pricing
HQ:
Long Beach, 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
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).
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical devices
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
1–14 days
Pricing model:
Per project
Included services:
510(k) submission (premarket notification for class II medical devices), Medical device label review for FDA compliance, Regulatory review for medical devices
Services Offered:
Device Classification Support, 510(k) Strategy & Authoring, Traditional 510(k) Support, Labeling Review for Submission (510(k)/De Novo/PMA)
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
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
No explicit mention of onboarding steps, required documents, or timelines.
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, medical device establishments, cosmetic facilities, and drug establishments.
Inspection Support
Yes, as a U.S. Agent, they assist 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.
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