If the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will place it on its import alert list to prevent the products from entering the U.S. But that is not a guarantee they won’t get in.
For the second time in recent months, the FDA has slapped a Chinese company with a warning letter after finding that it was buying products from a banned supplier, faking Certificates of Analysis (COA) and then shipping the APIs as their own.
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This time around, the warning letter was issued to Lumis Global Pharmaceuticals after a September 2016 inspection of its site in Wuhan. It said at least some of the APIs it was selling came from an unidentified supplier on the FDA import alert list.
Lumis would then generate a COA by copying and pasting information from the supplier into a document with its own letterhead and send that to customers.
“Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk,” the FDA said.
The warning listed a number of other violations tied to the faked documents and suggested the company hire a consultant if intends to keep shipping to the U.S.
It also dinked the company after it found unidentified material in the company’s “released for shipping” area. The investigator was told that this material was not going to be released to customers, but was in fact going to be destroyed. If that is the case, the FDA said the material should be relabeled and held under controls that would prevent its release.
It is the second time this year that a Chinese company has been warned about faking COAs and selling product from a banned supplier. In a January warning letter, the FDA made the same charges against the Suzhou Pharmaceutical Technology facility in Suzhou, Jiangsu Province. The FDA also noted that the company 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."