FDA Issues

Importing FDA Regulated Foods, Drugs, Cosmetics, Medical Devices, Veterinary Products, and Electronic Products (Radiation Emitting Products)

Process Problems and FDAImports.com Solutions

FDAImports.com, its consultants and affiliated attorneys, regularly handle domestic and international FDA and USDA related matters with particular focus upon compliance with FDA and USDA requirements for foreign origin (imported) products.

Failing to comply with FDA or USDA requirements can result in refusal or rejection of shipments intended for the US market. In addition, these governmental agencies may issue import alerts that are specific to product/manufacturer or shipper combinations resulting in a virtual importation ban of the affected products. It is important to understand the FDA importation process and how to comply with FDA requirements.

Follow these links to find additional information on matters relating to Customs and USDA authorities.

Domestic and International matters handled by FDAImports.com consultants and affiliated attorneys include:

FDA Import Process & Procedure

The Bioterrorism Act of 2002

FDA Import Alerts

Resolving FDA Entry Problems

Rescinding FDA Refusals

FDA Enforcement Actions: Administrative, Civil, and Criminal

Export & Import Requirements

FDA Labeling Requirements

FDA's Electronic Product Regulation

cGMPs and QSRs

cGMP Requirements for Dietary Supplements

Dietary Supplement Labeling

HACCP - Seafood & Juice Regulations

Responding to FDA Warning Letters, Untitled Letters & 483s

FDA’s Filer Evaluation Program

Food Ingredients & Additive (GRAS) Assessments

FDA Color Additive Requirements

FDA, EPA & Pesticides in Foods