Chinese API company found faking CoAs, selling potentially tainted products

FDA China
The FDA, which has upped its inspection presence in China, has issued warning letters to a Chinese finished drugmaker and an API supplier.

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.

The FDA suggested that if Suzhou intends to try to continue to sell into the U.S., it hire a consultant to get its operations up to FDA standards.

The letter to Sato Yakuhin Kogyo also tracked back to a June inspection when FDA inspectors discovered the Japanese company was found retesting batches that had failed a first test, then deleting data for those initial tests without explanation. It said the company didn’t bother to get to the root cause of the out-of-spec results.

The company agreed to upgrade computerized equipment and maintain audit trails for its products, but the FDA said it wants a whole lot more, including validation reports on its microbiological test method for finished drug products and for its swabbing recovery method.

The problems outlined in the letters were not unlike issues the FDA has found at other drugmakers. In the last couple of years, the FDA has significantly increased the number and frequency of foreign plant inspections, particularly in India and China, the largest producers of generic drugs and APIs. Last year it issued a series of warning letters to drugmakers in China, including some that do work with Big Pharma.

Editor's Note: The story was updated to point out that Sato Yakuhin Kogyo is a Japanese company.