Timing is Everything
When importing FDA-regulated products into the U.S., time is money. So, when you receive an FDA Notice of Action, a prompt and appropriate response will expedite what comes next.
Nearly 15% of U.S. imports are FDA-regulated products. That amounts to nearly $2.5 billion of goods imported annually manufactured in approximately 144,000 registered foreign facilities.
Tasked with ensuring public health and safety, FDA has the authority to conduct product examinations and/or sample collections to ensure compliance with regulations and laws. Importers must be prepared for FDA to execute this authority. Some inspections are routine, some are risk-based and some are in response to increased vigilance because of past violations.
What does an FDA Notice of Action mean? How should responses be handled?