FDA Specialist — FDA import detention and compliance consultants
24-48 Hour Response

FDA Detained Your Shipment? Get It Released — Fast.

Former FDA officials resolve import detentions, refusals, and Red List Import Alerts. Free 30-minute consultation — honest answers from people who worked inside the agency.

Former FDA Officials
24 Years FDA Experience
500+ Facilities Registered
Worldwide Consulting

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Free 30-minute consultation with a former FDA official

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IMPORT PROBLEMS WE SOLVE

Stuck With FDA? We've Seen It Before.

From a single detained shipment to a years-long Import Alert, our former FDA investigators know exactly what evidence the agency needs to release your products.

FDA Import Detention

Your shipment is on FDA hold at the port. We respond before the respond-by date with testimony, private lab reports, or reconditioning proposals.

FDA Import Alert Red List

Automatic detention without physical exam (DWPE). We prepare petitions with corrective actions to remove your products from the Red List.

FDA Import Refusal

Shipment refused and headed for re-export or destruction? We overturn refusals that resulted from FDA error or misjudgment.

Green List Petitions

Exempt your products from DWPE under country-wide Import Alerts with a thorough Green List petition backed by preventive controls.

FSVP Violations & IA 99-41

Importers flagged under Import Alert 99-41 for FSVP issues. We handle root-cause investigations and corrective action plans.

Label & Adulteration Charges

Salmonella, pesticide residue, unapproved additives, misbranding — we prepare the evidence and arguments FDA needs.

Not sure which category you fall under? Send us the notice — we'll tell you in the free consultation.

Request Free Consultation

OUR PROCESS

How We Get You FDA Compliant — Fast

A clear path from detention notice to released shipment

1

Free Consultation

Share your detention notice or Import Alert details. We review your charges, respond-by date, and options — no obligation.

2

Customized Action Plan

You receive a detailed strategy with timeline, costs, and the specific evidence FDA will require to release your products.

3

We Handle Everything

From private lab coordination and reconditioning proposals to drafting and submitting your FDA petition — we represent you before FDA.

4

Shipment Released

Your products clear FDA and Customs. For Red List cases, we shepherd the five clean shipments needed for removal.

24-48 Hour Response

Urgent detentions prioritized

Transparent Pricing

No hidden fees or upsells

Worldwide Clients

US importers & foreign exporters

WHY CHOOSE US

Why Leading Importers Choose FDA Specialist

Insider FDA knowledge, a track record of released shipments, and straightforward pricing you can budget against.

Former FDA Officials

Led by Richard Chiang — 13 years at FDA plus 11 years in industry. Get insider knowledge from someone who worked inside the agency.

Full-Spectrum FDA Expertise

Foods, dietary supplements, cosmetics, medical devices, and drugs — every FDA-regulated category covered under one roof.

Import Problem Specialists

Detentions, refusals, Import Alerts, and Red List petitions are our core practice, not a side offering.

Transparent Pricing

No hidden fees, no upselling. We fix your FDA problem — we don't pad the invoice with services you don't need.

Proven Track Record

500+ facilities registered and a long record of successful petitions, reconditioning proposals, and refusal reversals.

Worldwide Consulting

US importers and foreign manufacturers across China, India, Mexico, Korea, Italy, Germany, Thailand — wherever FDA reaches.

Ready to Get Your Shipment Released?

Schedule a free 30-minute consultation with a former FDA official. We'll review your notice or Import Alert and tell you exactly what it takes to resolve it.

MEET THE CONSULTANT

Former FDA Officials on Your Side

Richard Chiang, Former FDA Official and CEO of FDA Specialist

Richard Chiang

CEO & Chief FDA Consultant

Richard Chiang spent 13 years inside the FDA as an investigator and compliance officer before founding FDA Specialist.

He now leads a team of former FDA officials and industry technical experts helping importers, manufacturers, and exporters resolve detentions, clear Import Alerts, and meet FDA requirements across foods, cosmetics, medical devices, and drugs.

Richard has been featured on Inside the Blueprint discussing FDA regulation strategy for the import community.

13
Years at FDA
11
Years in Industry
500+
Facilities Registered

Experience & Background

  • 13 years as FDA investigator & compliance officer
  • 11 years in the FDA-regulated industry
  • Extensive experience with Import Alert petitions & reconditioning proposals
  • US Agent services for foreign food, cosmetic, drug, and device facilities

TESTIMONIALS

What Our Clients Say

Real outcomes for importers, manufacturers, and brokers

"FDA had our shipment on hold at LAX. Richard's team responded with the right evidence before the deadline — released in two weeks."

Manufacturer

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"We were on an Import Alert Red List for over a year. They built the petition and corrective action plan that finally got us off."

Importer

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"Transparent from day one — they told us exactly which charges could be overcome and which couldn't. No wasted money."

Customs Broker

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500+
Facilities Registered
24
Years FDA Experience
24-48h
Typical Response
Free
30-Min Consult

FAQ

Frequently Asked Questions

FDA detentions, Import Alerts, and Red List removal

What should I do if my product is detained by the FDA?

Respond to the detention notice before the respond-by-date with evidence of compliance (such as a private lab report) or a reconditioning proposal. Missing the deadline typically leads to refusal, which is significantly harder to overturn. If you received a Notice of Detention and Hearing, contact us right away — the faster we start, the more options you have.

How long does the Import Alert Red List removal process take?

Timelines vary. Red List removal generally requires at least five consecutive clean commercial-size shipments that FDA detains and then releases without finding a violation, plus a corrective-action petition detailing how you identified and fixed the root cause. In practice this is often several weeks to several months depending on shipping frequency and lab turnaround.

How fast can you respond to a detention notice?

Typically within 24-48 hours of your free consultation. Urgent cases near the respond-by-date are prioritized. The moment you forward us your detention notice, we start reviewing the charges and mapping out what evidence FDA will accept.

Can you help if FDA already refused my shipment?

Yes. Refusals are harder than detentions, but we've successfully overturned refusals that resulted from FDA error or misjudgment. Once a shipment is refused, you must redeliver to Customs custody (usually within 90 days) and either export or destroy under FDA/Customs supervision — unless compelling evidence proves FDA made a mistake. The clock is tight, so contact us quickly.

Do I need a US Agent for FDA food facility registration?

Yes. Foreign registrants must have a US Agent located in the United States who can receive communications from FDA and help schedule inspections. FDA Specialist can serve as your US Agent for food, dietary supplement, cosmetic, medical device, and drug facilities.

What counts as a "clean shipment" for Red List removal?

A routine, commercial-size shipment (roughly $2,500+ in value, the threshold for a formal Customs entry) that FDA detains and then releases without finding any violation. Five consecutive clean shipments — adequately spaced apart and actually detained by FDA — are typically required. Small samples or artificially split shipments do not count.

Do you work with foreign manufacturers and exporters?

Yes. We serve exporters in China, India, Mexico, Korea, Italy, Germany, Thailand, and worldwide — including country-wide Import Alert issues and Green List petitions. If your products are subject to DWPE under a country-wide Import Alert, we can help you petition for Green List status.

Still have questions about your detention notice or Import Alert?

Call us at (562) 882-4981

Stuck in FDA Limbo? Let's Fix It.

Unsure if your shipment can be released or if you qualify for Red List removal? Schedule a free 30-minute consultation with a former FDA official. Honest answers, clear roadmap, no high-pressure sales.

Former FDA Officials
24-48 Hour Response
Free 30-Min Consult
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