Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained.
Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
The logistics of importing products complicates the process further and you must know the consequences of your decisions. Some problems can cost you time and money, especially when you do not work promptly with the FDA. If you end up with having your entry "refused." There is no appeal. Then you face the possibility of additional steep fines by CBP and be blocked from the U.S. market.
Firms typically run aground with importing FDA regulated products because they do not understand how to prepare, conduct and report information in accord with FDA requirements. That mire of activity starts before you even ship a product to the U.S. If the exporter and importer do not follow the procedures or fail to submit correct information, the road forward has an expensive and time-consuming toll.
A failure to do things correctly will create a "bad actor" image, which is very hard to undo and FDA does not forget, somewhat like a regulatory elephant. It is true. If you understand FDA's and CBP's import program, your business can operate in a competitive way. If you do not, your customers, foreign suppliers, and stockholders will see the consequences and not be forgiving.