Misbranded is the legal term for non compliant with FDA regulations.
A misbranded product could be detained by the FDA and U.S. Customs at any U.S. port or airport.
Your product may be detained because it appears to be:
■ adulterated – the product is contaminated, is not safe, or does not otherwise meet applicable standards
■ misbranded – the labels contain false or misleading information
■ an unapproved new drug
■ manufactured, processed, or packed under insanitary conditions
■ forbidden or restricted for sale in the country in which it was produced or from which it was exported.
At the time of importation, the FDA will verify compliance with the following requirements as applicable:
Certain medical devices may need to comply with Premarket Submission requirements (Premarket Notification or Premarket Approval).
The FDA conducts field examinations and analyzes samples of medical devices to ensure they comply with applicable standards and/or label requirements.
Also, the import alert database is checked to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert. For example, import alert 89-04 lists foreign manufacturers not in compliance with Medical Device Good Manufacturing Processes.
The agency uses the internal data systems to verify registration, listing, device approval (when required), or other product requirements and the declared manufacturer, importer/consignee, to determine if the firm is subject to detention without physical exam (DWPE). If the information submitted matches, then compliance is verified. Otherwise, the FDA may gather additional information or may detain the product.
The submission of correct and accurate entry data along with the relevant A of C (Affirmations of Compliance) codes will help expedite the entry review process.