A Taiwanese API maker is in hot water with the FDA, which has issued it a warning letter after an inspection in which investigators found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned.
The warning letter was issued Sept. 15 to Taoyuan City-based Cheng Fong Chemical and posted today after an inspection in April.
The letter says said that among other problems, the plant had not been adequately investigating customer complaints of black particles in APIs. In fact, the report says that after getting a complaint, Cheng Fong investigated another batch, where it also found black particles, but then didn’t bother to find the root cause of particulate for either batch.
The company said the source was probably from equipment that was in poor condition. The investigators did find equipment that was corroded, dirty, pitted on the product surface of the equipment and leaking on and around the equipment. But it said the company had not determined for sure that was the cause.
Investigators also found cold rooms storing raw materials and intermediates used to make APIs that had foul odors and which officials acknowledged “had never been cleaned.”
The FDA told the company that it needs to resolve its customer complaints by figuring out the source of the black particulate, and update and assess its maintenance program.
The FDA is putting more resources into inspecting Asian manufacturers and some need big improvements. Earlier this year, the FDA issued a warning letter to Taiwanese API maker KO DA Pharmaceutical after finding the plant had no written procedures for production and process controls or for the preparation of master production and control records to assure batch uniformity. Rather than fix the problems, KO DA told the FDA it instead would simply quit exporting to the U.S. the one product it was selling there.
- read the warning letter
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