Another Chinese drugmaker has run afoul of the FDA. After banning the imports of Hangzhou Guoguang Touring Commodity in October, the agency has now slapped its finished pharmaceutical plant with a warning letter.
The warning letter was posted last week after agency employees returned from furloughs tied to a government shutdown that began in December. The FDA said inspectors found a facility with almost no controls on the over-the-counter products it was shipping to the U.S. The FDA said the best thing the company could do at this point is get an outside consultant that can show it how to manufacture drugs to FDA standards.
For example, not only had Touring failed to do any validation studies to show its equipment cleaning processes were able to prevent cross contamination, it was violating FDA standards by using the same equipment to produce both drugs and nonpharmaceutical products. Its products include baby wipes, hand sanitizers and contact lens solutions as well as car leather cleaners and wipes for the aviation industry.
Its quality control unit was not doing its job, the letter said. Four batches were shipped even though test results from its contract lab showed they were out of spec. Another batch was released before a test for assay had been completed. Finally, the FDA said it didn’t have an adequate testing program that showed products met specifications.
RELATED: FDA’s aggressive move on tainted ‘sartan’ leads to shortages
The problem came even as new questions are being asked about Chinese producers after probable cancer-causing impurities were found in the valsartan API of a Chinese company. The problems were discovered in the APIs of Zhejiang Huahai Pharmaceutical, which resulted from manufacturing changes, including the reuse of solvents. While the same impurity has been found in the ‘sartan’ products of other drugmakers, including U.S.-based Mylan, the FDA has said the levels in Huahai’s drugs were much higher than those of other producers.
The concerns over the issue have led to a global recall and prompted the FDA to order new tests for certain products. Now shortages of the essential blood pressure meds have materialized as the industry responds to the problems.
