FDA inspectors have come down hard on a drugmaker in Taiwan, issuing a warning letter to Taiwan Three Mast Pharmaceutical in Tainan City for serious manufacturing violations.
In its report, issued in December and filed this month on its website, FDA inspectors told the company that they discovered that Three Mast was not even testing APIs to find out if finished products met strength criteria. In fact, the company had no written procedures to make sure that happened.
"Your manufacturing processes for Imbue Pain Relief Patch, Panlax Herbal Patch, Panlax Herbal Balm, and Panlax Herbal Cream are not validated. Your firm has manufactured and distributed these drug products to the U.S. market since 2010," the warning letter says.
Further, there was no indication that its employees had either the knowledge or sufficient training to ensure that they knew what they were doing. On top of that, the company had no procedures in place to follow up with any problems that were discovered with products. It was not reviewing the reasons for "recalls, returned or salvaged drug products" or getting to the causes of "deviations or batch failures."
The FDA has said that with new authorities given it under legislation that added fees to generic drugmakers, it expects to do many more foreign plant inspections, particularly in places like mainland China. In testimony to Congress last year, Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research, pointed out that there are now more foreign drugmakers than U.S. drugmakers for it to inspect. The law also will allow drugmakers to hire nongovernment inspectors to assess whether factories are meeting U.S. quality standards and offer their data to the FDA as support of the companies' manufacturing processes.
- read the warning letter