With countries all over the world building up their drugmaking capabilities, the FDA is working to keep up with inspections of existing plants even as more come online. In fact, the FDA says there are now more foreign than U.S. plants that it must keep tabs on. When FDA inspectors do get in them, they often find that facilities that have been exporting products to the U.S. for years are not meeting some of the most basic manufacturing standards.
A warning letter posted today on the FDA website for a operation in Taichung City, Taiwan, illustrates the challenge. Inspectors found that the Beanne Chemical facility failed to validate its manufacturing processes; was not conducting in-process testing, only finished-product testing; and was not testing for stability that would support expiration dates.
When inspectors asked for laboratory raw data used to support the release of finished lots, the company said it didn't keep it. This meant that there was no way of knowing if analysis for such things as "total aerobic microbial count, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, arsenic, lead, mercury" met specs. The FDA said it also means that it is not possible for the company to be sure that APIs in its products met labeled levels. The FDA told the company that it not enough to provide the agency with a plan for going forward. The agency wants to know what it intends to do about the drugs it has already released.
With additional funding from fees on generic drugmakers, the FDA expects to step up foreign plant inspections, particularly in places like mainland China where thousands of plants are now operating and offering bulk APIs online. But with the ever expanding number of operations, the agency also is looking for ways to work cooperatively with regulators from other countries. The new law also will allow the most trusted 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.
- here's the FDA warning letter