It’s a sliding scale and you really need to know how FDA uses the system in order to obtain removal.
Glen Burnie, MD (PRWEB) December 17, 2012
The FDA regulatory consultants and affiliated attorneys at FDAImports.com recently achieved another success for one of their clients, obtaining removal from an FDA Import Alert for cosmetics. The client, a Chinese cosmetic firm, was placed on FDA Import Alert 53-06, “Detention Without Physical Examination Of Cosmetics Containing Illegal Colors,” because a previous entry of product tested positive for an illegal color additive.
The complicating factor in this case was that the product in question was a limited run so sending five additional clean shipments to aid in obtaining removal from Import Alert was not possible. The team at FDAImports.com understood this and was able to find alternative means to persuade the Agency to remove the manufacturer from import alert. “Five clean entries used to be the rule of thumb,” said Benjamin England, Founder and CEO of FDA consulting firm, FDAImports.com. “Obtaining removal from Import Alert just isn’t a fixed science,” he stated. “It’s a sliding scale and you really need to know how FDA uses the system in order to obtain removal.” The international firm has helped numerous clients obtain removal from FDA’s Import Alerts system- a system which succeeds in preventing unsafe products from entering the United States but also catches many compliant companies in its wide net.
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.