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FDA Food Import

Label Review – Full report explaining all the changes that must be made to bring the food label into compliance with U.S. federal regulations. We also offer label design services as well (ask for details).

Regulatory Report: Full report explaining the federal regulatory requirements for the food product, identifying any potential problems for marketing the product in the US, and advising how to resolve or prevent those problems.

Food Facility Registration: FDA registration of facilities that manufacture, process, pack, or hold the food for distribution in US commerce.

US Agency: Act as US Agent for foreign food facilities (required for FDA registration of foreign facilities).

Food Canning Establishment (FCE) and Scheduled Process Identification (SID) Filing: Assisting manufacturers of low-acid canned food (LACF) or acidified food products with registration (obtaining FCE number) and process filing (obtaining SID).

Foreign Supplier Verification Program (FSVP) Development – FDA now requires most FDA-regulated imported foods to be covered by FSVPs which include analysis of food safety-related hazards and risk evaluation, supplier approval and performance evaluation, and documentation of any corrective actions.

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FDA Medical Devices Import

Label Review: Report detailing all changes that must be made to bring the device label into compliance with U.S. federal regulations. We also offer label design services as well (ask for details).

Regulatory Review: Full report explaining the federal regulatory requirements for your medical device product, identifying any potential problems for marketing the product in the US, and advising how to resolve or prevent those problems.

Medical Device Establishment Registration: FDA registration of medical device establishments. 

Medical Device Listing: Obtain listing number which is required for all medical devices intended for human use.

510(k) Submission: Submit premarket notification (“510k”) applications which are required for most class II medical devices.

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FDA Cosmetics Import

Label Review: Report explaining all the changes that must be made to bring the cosmetic label into compliance with U.S. federal regulations. Includes ingredient review. We also offer label design services as well (ask for details).

Regulatory Review: Full report explaining the federal regulatory requirements for your cosmetic product, identifying any potential problems for marketing the product in the US, and advising how to resolve or prevent those problems.

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FDA Drug Import

Label Review: Report listing all changes that must be made to bring the drug label into compliance with U.S. federal regulations. We also offer label design services as well (ask for details).

Regulatory Review: Full report explaining the federal regulatory requirements such as requirements for ingredients, doses, formulation for your drug product and identifying any potential problems in marketing the product in the US - and advising how to resolve or prevent those problems.

Drug Facility Registration: FDA registration of drug establishments.

Drug Listing: Obtain drug listing number which is required for all drug products.

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FDA Product Import

FDA Detention/Hold Resolution: Seeking FDA release of products on FDA hold or detention. We also can assist companies seeking to have FDA overturn refusals that resulted from FDA error or misjudgment.

Import Alert “Red List” Removal: Preparing and filing petition to remove products from Import Alert Red Lists including preparation of corrective action plans and root-cause investigation reports to ensure the company and its products are removed from the Red List as quickly as possible.

Import Alert “Green List” Addition: Preparing and filing petition with FDA to gain exemption from an Import Alert.

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

Contact Us

Phone: (562) 882-4981
richard@fdaspecialist.com

5318 E. 2nd St. No. 198
Long Beach, CA 90803

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*FDA Specialist, LLC is a private consulting company and is in no way affiliated with the United States Food and Drug Administration or other government agency.