The companies include China’s Jiangsu ZW Pharmaceuticals Co. Ltd., which received a warning letter in 2015, and Wuxi Kaili Pharmaceutical Company, which also received a warning letter in 2015, as well as India-based Fleming Laboratories, which received a warning letter in 2014, and Sharon Bio-Medicine Limited, which received a warning letter in 2015. FDA has been cracking down in recent months on noncompliant pharmaceutical and device companies across Asia, as well as in India and China specifically.
“Placing these firms on import alerts is the first time the FDA is using the authority provided by Congress to enforce GDUFA’s user fee provisions,” FDA spokesman Kris Baumgartner told Focus.
“In GDUFA, Congress authorized FDA to assess fees for facilities identified, or intended to be identified, in approved or pending generic drug submissions, including abbreviated new drug applications (ANDAs) and any amendments or prior approval supplements to ANDAs, for dedicated use in FDA’s human generic drug activities,” FDA explains. “Pursuant to GDUFA, FDA assesses an annual facility fee [which for FY 2016 foreign finished dose facilities was $258,905].”
FDA also makes clear that Section 502(aa) of the Federal Food, Drug, and Cosmetic Act provides that any drug or active pharmaceutical ingredient manufactured, prepared, propagated, compounded or processed in a facility for which the required fees have not been paid or required self-identifying information has not been submitted, are deemed to be misbranded and may be subject to refusal of admission to the US.
Companies on the so-called “Red List,” which only currently includes these four companies from India and China, were notified individually and in writing, some by warning letter, that they are in violation of the regulations, the agency said.
“The owners of these facilities have not made significant efforts to correct the violations during the time allotted in the communication notifying them of the violation,” FDA said.
For guidance on how companies can be removed from such a list, FDA points industry to its, “Regulatory Procedures Manual, Chapter 9, ‘Detention Without Physical Examination (DWPE).’”
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