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Monday, January 23, 2017

Chinese API company found faking CoAs, selling potentially tainted products

The FDA discovered that a Chinese company peddling active pharmaceutical ingredients (API) in the U.S. was selling APIs from another supplier and claiming it had manufactured them itself. The big problem was the original supplier of some of those was on an FDA import alert list at the time.

The FDA outlined the problem, among a host of others, in a warning letter to the Suzhou Pharmaceutical Technology facility in Suzhou, Jiangsu Province. The warning letter was one of two posted Tuesday that were sent to Asian producers.  The other was to Sato Yakuhin Kogyo, a solid-dose finished drugmaker in Kashihara City in Japan that the FDA cited for serious data integrity issues.

As for Suzhou Pharmaceutical, the FDA said its June 2016 inspection found that the company was creating fake certificates of analysis (CoA) for the products it was selling by copying and pasting analytical results from the original API manufacturer, replacing the manufacturer's information with its own letterhead, then issuing the CoAs to its customers.

In fact, Suzhou didn't have a quality assurance unit to test the APIs it sells. Instead, it had salespeople sign off on the certificates, using the title "QC Director." On top of that, the APIs were being stored in a facility with no temperature controls and no assurance they were not compromised.


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