FDAImports.com recently assisted a Chinese company with removal from FDA Import Alert 53-17, “Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.” This case is of particular interest, because it is a reminder that FDA makes mistakes too. In this case, FDA wrongly added the company to Import Alert even though the cosmetic presented no actual safety risk or violation.
FDA Import Alert 53-17 is a very common Import Alert for cosmetic products with China, Mexico, and Canada having the most companies listed. Typically, an Import Alert listing comes from FDA finding microbiological contamination in a cosmetic, such as eyeshadow, eye makeup and lipsticks. A single sample testing positive for a problematic bacterium in a high enough concentration will cause FDA to place the entire product category from the manufacturer on this Import Alert.
In the case of the Chinese company, a sample of their eyeshadow product tested positive in a very low amount for a common bacterium found on human skin. When the company contacted FDAImports.com for assistance with removal from the Import Alert, red flags went off immediately regarding FDA’s actions. The FDAImports.com team proved to FDA that the Agency had made an error, and as a result FDAImports.com convinced FDA to remove the firm from Import Alert 53-17 without requiring the usual 5 clean shipments.
Don’t Learn the Hard Way
The lesson to learn here is that companies need to advocate for their own compliance and not assume that FDA is always right. FDA makes mistakes. We’re always encouraging companies to import and distribute their product with a compliance partner so that when FDA wrongly accuses, fines, detains or refuses your product- you’ll be ready.
Need Help?
FDAImports.com routinely assists companies in petitioning for removal from FDA Import Alert and getting their shipments released. Contact us now to get started.
