We offer comprehensive support for food exporters targeting the US market. From FDA filings and facility registration to navigating import regulations and addressing detention issues, we’re your one-stop shop for compliance.
We help you proactively maintain compliance with US-FDA regulations through third-party audits and process deviation evaluations. Should issues arise, we provide expert support with import detentions, alerts, and inspection reports, ensuring your products reach the US market.
Filing products with the FDA for export to the US FDA involves much more than filling out forms. Technical compliance of your aseptic processing and packaging system must be demonstrated throughout a third-party audit. Our professionals have 30+ years of experience in the field. Let us help you making the journey throughout US exports a smooth one!
We offer assistance when FDA issues a notice of detention that stops the product from entering the US. Detentions happen whenever a product seems to violate FDA regulations. Product detentions are costly and could damage the company reputation if not handled fast and properly. When FDA issues an import alert, the product is automatically detained. To remove an import alert, the processor must send to FDA proof that the product complies with FDA regulations. This process can be long and costly.
Process deviations often occur in every processing plant. Appropriate handling of the product and disposition determination can be a real headache. Let us help you with that! By reviewing the processing deviation documentation, making calculations, and occasionally performing further testing, we can determine the appropriate product disposition. We also write the process deviation letters, which are mandatory for any product for the US market that undergoes a process deviation.