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 regulatory compliance services for companies importing food, dietary supplements, cosmetics, medical devices, and drugs into the United States. Led by Owner and Chief Consultant Richard Chiang, the firm focuses on navigating complex FDA regulations.
**Expertise & scope**
* **Food Compliance:** Services include facility registration, US Agent representation for foreign facilities, Foreign Supplier Verification Program (FSVP) compliance, low-acid canned food (LACF) and acidified food regulations, prior notice, and label requirements.
* **Medical Device Compliance:** Expertise covers regulatory classification (Class I, II, III), establishment registration, US Agent services, device listing, and premarket notification (510k) or approval processes.
* **Cosmetic Compliance:** Support includes cosmetic facility registration, product listing, ingredient and product safety assessments, and adherence to labeling requirements, especially under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drug Compliance:** Services encompass establishment registration, drug listing, adherence to Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Alerts & Detentions:** Assistance with understanding and resolving FDA Import Alerts, including petitioning to be removed from the Red List and managing import detentions, offering guidance on evidence of compliance and reconditioning.
**Reputation / proof points**
* Services are designed to ensure US food supply safety and compliance with regulations like the Food Safety Modernization Act and the Bioterrorism Act.
* Expertise in resolving import holds, detentions, and import alert petitions.
FDA Specialist provides comprehensive regulatory compliance services for companies importing food, dietary supplements, cosmetics, medical devices, and drugs into the United States. Led by Owner and Chief Consultant Richard Chiang, the firm focuses on navigating complex FDA regulations.
**Expertise & scope**
* **Food Compliance:** Services include facility registration, US Agent representation for foreign facilities, Foreign Supplier Verification Program (FSVP) compliance, low-acid canned food (LACF) and acidified food regulations, prior notice, and label requirements.
* **Medical Device Compliance:** Expertise covers regulatory classification (Class I, II, III), establishment registration, US Agent services, device listing, and premarket notification (510k) or approval processes.
* **Cosmetic Compliance:** Support includes cosmetic facility registration, product listing, ingredient and product safety assessments, and adherence to labeling requirements, especially under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drug Compliance:** Services encompass establishment registration, drug listing, adherence to Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Alerts & Detentions:** Assistance with understanding and resolving FDA Import Alerts, including petitioning to be removed from the Red List and managing import detentions, offering guidance on evidence of compliance and reconditioning.
**Reputation / proof points**
* Services are designed to ensure US food supply safety and compliance with regulations like the Food Safety Modernization Act and the Bioterrorism Act.
* Expertise in resolving import holds, detentions, and import alert petitions.
Additional information
FDA Specialist assists foreign entities in meeting US FDA requirements, acting as a crucial liaison. For food importers, this includes ensuring FSVP compliance, which mandates documentation verifying that imported foods meet US food-safety standards. A 'qualified individual' with relevant education or experience must perform and document FSVP activities, including hazard analysis and risk evaluation for each imported food. For medical devices, understanding the classification (Class I, II, or III) is key to meeting specific FDA requirements, with options like premarket approval or the de novo pathway for lower-risk devices. Companies should be aware that FDA can detain imported products without physical examination if they are listed on an Import Alert's Red List due to previous violations.
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 US Agent services for foreign facilities, ensuring communication and assistance with FDA inspections.
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 and assist FDA with scheduling inspections of the foreign facility.”
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Assists with 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.”
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Expertise in resolving FDA Import Alerts and managing import 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 and is implementing specific, corrective actions that will prevent future violations.”
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 needing a US Agent for FDA compliance.
- Businesses seeking to navigate FDA regulations for food, drugs, cosmetics, or medical devices.
- Importers dealing with FDA import alerts or detentions.
How engagement typically works
- Consultative approach to regulatory challenges.
- Focus on practical solutions for compliance issues.
Typical deliverables
- US Agent representation.
- Facility registration and product listing support.
- Guidance on FSVP, GMP, and other regulatory requirements.
- Assistance with import alert resolution and detention management.
Good to know
- Best when requiring specialized FDA regulatory expertise for US market entry or ongoing compliance.
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, drug establishments, and cosmetic facilities.
Inspection Support
Yes, as a US Agent for 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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