- Don’t Wait to Act Until FDA Adds the Company to Import Alert
Waiting until you get red-listed before identifying what happened and fixing it is a big time-and-money mistake. However, if you wait until your company is added to an import alert, you will likely have a harder time conducting an investigation – which is necessary for a successful import alert petition. Removal from import alert might require a certain number of consecutive shipments that tested clean when imported, or records documenting implementation of new or revised procedures, such as a seafood HACCP alert or one related to Good Manufacturing Practices violations.
Being proactive about solving the problems that caused an import alert listing will help you save time, money, and the public shaming that comes with a delayed response to an import alert. If you move fast enough, FDA may be willing to remove your company from Import Alert before it’s even been publicly listed.
- FDA Doesn’t Always Wait to Refuse a Shipment Before Initiating an Import Alert Listing
The process to add a company to import alert may begin as soon as FDA detains an entry. While this FDA policy can be port-specific, it is more and more common for local FDA compliance officers to recommend a company and its product for import alert at the same time that they issue the first detention notice.
In such a case, FDA is relying on the evidence they collected to detain the entry to also make the recommendation to import alert. Failing to analyze and challenge FDA’s detention evidence can mean addition to import alert – even if FDA relied on faulty evidence. Acting proactively on a detention notice can prevent the headache of trying to remove your company from import alert later. FDAImports.com helps clients analyze the evidence and identify the best possible solutions in dealing with an FDA detention and a pending import alert recommendation.
- FDA Will Get Around to It
Some ports are not as proactive in recommending that a company be added to import alert. In some cases, FDA will find evidence to detain and refuse an entry, and much later – sometimes nine months or a year later – the port will recommend addition to import alert. It is important to not wait for FDA to make the first move. If, as soon as a violation is found, you start collecting the evidence needed to petition the Agency, then you are making use of valuable time and working on your own schedule. Generally, being added to import alert happens at the worst possible time (with 20 containers already on the water and a high demand from customers).
- Collecting the Evidence Can Take Months, Even Years
Early assessment of a violation that will lead to an import alert is vital; your evidence collection process becomes less burdensome, more thorough, and more reliable. FDA’s Regulatory Procedural Manual (RPM) states that “a minimum of five (5) consecutive non-violative commercial shipments should be entered before the agency may consider that the appearance of the violation has been overcome, and that it may become appropriate to remove the detention without physical examination (emphasis added).” Notice, this is not a rule – although FDA tends to treat it like one. Once a company is on import alert, it can be difficult to persuade FDA to remove the company using any evidence other than what the RPM recommends.
For example, attempting to remove a company from import alert with no clean entry history since the violation, or using foreign lab results instead of US labs results, can be a challenge – but it is not impossible. You may not have the resources to bring in commercial-sized entries every few weeks to gather the “minimum” number of clean entries or to pay private labs to analyze each entry. However, FDAImports.com has significant experience identifying and collecting only what is necessary for a successful petition, and presenting non-conventional forms of evidence, proving compliance and saving you time and money.
- Import Alerts are Not Just for Manufacturers
FDA designed the import alert system to shift the burden of evidence (sampling, testing, etc.) to the “violator,” with the effect of disrupting the supply chain for a company that has a history of importing noncompliant shipments into the U.S. The import alert system is an effective way to require testing or some documentation of compliance before entries enter U.S. commerce. However, FDA is using import alerts for importers, retailers, individuals, and even geographic areas and countries (area-wide and country-wide import alerts).
But, the pain does not stop with just the firm/country/individual listed on the import alert. Often, other actors in the supply chain may have to assist, either financially or risking their own import record, in order to help remove a business partner listed on import alert. The financial and regulatory risks are far-reaching.
FDA Import Alerts don’t have to be permanent – but if you do nothing, they will be. You can do something to move your company onto the Green List or off of the Red List. If your company is on Import Alert, contact us to review your case!
