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.
Free 30-minute consultation with a former FDA official
IMPORT PROBLEMS WE SOLVE
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.
Your shipment is on FDA hold at the port. We respond before the respond-by date with testimony, private lab reports, or reconditioning proposals.
Automatic detention without physical exam (DWPE). We prepare petitions with corrective actions to remove your products from the Red List.
Shipment refused and headed for re-export or destruction? We overturn refusals that resulted from FDA error or misjudgment.
Exempt your products from DWPE under country-wide Import Alerts with a thorough Green List petition backed by preventive controls.
Importers flagged under Import Alert 99-41 for FSVP issues. We handle root-cause investigations and corrective action plans.
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 ConsultationOUR PROCESS
A clear path from detention notice to released shipment
Share your detention notice or Import Alert details. We review your charges, respond-by date, and options — no obligation.
You receive a detailed strategy with timeline, costs, and the specific evidence FDA will require to release your products.
From private lab coordination and reconditioning proposals to drafting and submitting your FDA petition — we represent you before FDA.
Your products clear FDA and Customs. For Red List cases, we shepherd the five clean shipments needed for removal.
Share your detention notice or Import Alert details. We review your charges, respond-by date, and options — no obligation.
You receive a detailed strategy with timeline, costs, and the specific evidence FDA will require to release your products.
From private lab coordination and reconditioning proposals to drafting and submitting your FDA petition — we represent you before FDA.
Your products clear FDA and Customs. For Red List cases, we shepherd the five clean shipments needed for removal.
Urgent detentions prioritized
No hidden fees or upsells
US importers & foreign exporters
WHY CHOOSE US
Insider FDA knowledge, a track record of released shipments, and straightforward pricing you can budget against.
Led by Richard Chiang — 13 years at FDA plus 11 years in industry. Get insider knowledge from someone who worked inside the agency.
Foods, dietary supplements, cosmetics, medical devices, and drugs — every FDA-regulated category covered under one roof.
Detentions, refusals, Import Alerts, and Red List petitions are our core practice, not a side offering.
No hidden fees, no upselling. We fix your FDA problem — we don't pad the invoice with services you don't need.
1000+ facilities registered and a long record of successful petitions, reconditioning proposals, and refusal reversals.
US importers and foreign manufacturers across China, India, Mexico, Korea, Italy, Germany, Thailand — wherever FDA reaches.
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
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.
TESTIMONIALS
Real outcomes for importers, manufacturers, and brokers
"Our shipment sat in FDA hold at the port for two weeks with the clock running on storage fees. Richard's team pulled together the lab reports we needed and got it released before we lost the whole container."
Daniel O.
Founder
"We'd been stuck on FDA's Import Alert list for over a year before we found FDA Specialist. They built our corrective action petition and walked every shipment through until we were finally removed."
Linh P.
CEO
"I've worked with consultants who overpromise. Richard told us upfront which charges we could fight and which we couldn't, then stuck to that plan. No surprise invoices."
Robert K.
Operations Director
FAQ
FDA detentions, Import Alerts, and Red List removal
Still have questions about your detention notice or Import Alert?
Call us at (562) 882-4981Unsure 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.
