FDAImports.com Assists Chinese Firm with Removal From FDA Import Alert 53-17, Microbiological Contamination in Cosmetics

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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.”

FDA Import Alert 53-17 is a very common Import Alert for cosmetic products with China, Mexico, and Canada having the most companies listed.

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.” In this case the U.S. Food and Drug Administration wrongly added the company to Import Alert even though the cosmetic presented no actual safety risk or violation. The FDAImports.com team was able to discover the error and make the case to FDA for the removal of this cosmetic firm from the Import Alert.

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, it was immediately apparent that there was not a safety risk and that FDA had made a mistake. 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.

Source
accessdata.fda.gov/cms_ia/importalert_136.html

About FDAImports.com
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 220-2800 or pr(at)fdaimports.com.

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