FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts. An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why they should not be on Import Alert. FDAImports.com is pleased to report on two recent success stories of obtaining removal from FDA Import Alert on relatively short time frames.
Case #1: Sunglasses (Import Alert #86-07)
FDA began automatically detaining shipments of imported sunglasses because the Agency had added the manufacturer to Import Alert (Import Alert #86-07: Impact-Resistant Lenses in Eyeglasses and Sunglasses). The FDAImports.com team worked with the manufacturer to obtain and assemble the necessary evidence to petition FDA to remove the manufacturer from the Import Alert by demonstrating that FDA added the wrong company to the import alert! In turn, FDAImports.com obtained multiple FDA releases for automatically detained entries and even some FDA refused entries based on removal of the manufacturer from Import Alert #86-07. All of this was accomplished without domestic testing for the sunglasses.
Import Alert Lesson #1: FDA makes mistakes too! Detecting that mistake in the evidence and proving it to FDA makes the difference between an eight-month delay and a one-month delay. Do not assume that FDA is interpreting the evidence correctly.
Case #2: Snack Products (Import Alert #23-14)
Another recent case involved a Mexican food manufacturer. In October 2010 an entry of snack products tested positive for aflatoxin, a toxic form of mold common in various grains. Within a few weeks of the positive tests, the manufacturer had replaced its raw material supplier and initiated an aflatoxin-testing plan that completely eliminated the problem. FDA even tested several shipments and released them as clean shipments. Nevertheless, six months later in April of 2011, FDA added this manufacturer and its product on FDA Import Alert #23-14 for Aflatoxin contamination – six months later!
At the end of May the FDAImports.com team stepped in to assist the manufacturer. FDA had already automatically detained 60 shipments, which grew to over 100 entries (consisting of tens of thousands of product units). FDAImports.com presented evidence to FDA demonstrating the cause of the problem (six months earlier) had already been identified and removed and FDA had actually validated that fact with its own later testing. Utilizing a limited product testing scheme several entries were released in June and July. FDAImports.com obtained agreement from FDA to hold in abeyance all other entries until it could convince FDA headquarters to remove the firm from Import Alert #23-14, which happened on July 13, 2011. Since then the importer has obtained over 100 FDA release notices and nearly two-dozen cancelations of Customs Demands for Redelivery.
Import Alert Lesson #2: When FDA delays, use it to get FDA to expedite the solution. How many times has FDA refused a shipment because an importer missed a deadline to file private laboratory reports by a day (or less)? That principle cuts both ways.
Additional Links and Resources
• How does a company get on an FDA Import Alert?
• To view a list of all Import Alerts by number click HERE.
• To view a list of the most recent Import Alerts click HERE.
• To view a list of Import Alerts by Industry click HERE.
• To view a list of Import Alerts by Country click HERE.
