FDA Warns Korean, Chinese Drugmakers

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

For Wuxi City-based Wuxi Medical Instrument Factory, FDA last March uncovered four violations, including one that involved the firm lying to FDA about when some documents were created.

"The records, covering January to March, 2017, were signed by two employees, and indicated that sanitization had been completed and verified contemporaneously throughout this period. However, our investigator found that these operations were not documented at the time of their actual performance, but were instead created and completed on March 7, 2017, the second day of the inspection," the letter said.

FDA also found that Wuxi could not provide process qualification batch records and quality control test documentation, and only provided the agency with "a protocol and a summary report with insufficient data."

For Firson, FDA inspectors last November found the Seobuk-gu-based site failed to demonstrate that its aseptic processes can prevent microbial contamination and that the site lacked a robust process to sterilize drugs.

The agency also took issue with the company's quality unit and investigations into cited problems.

"Your investigations lacked critical elements that help determine root causes. For example, the three investigations lacked an evaluation of the manufacturing process and associated records. You also did not routinely test complaint lots for all relevant quality attributes (e.g., sterility). Despite missing critical elements, your investigation concluded that 'there are no problems' with the implicated lots. Without thorough investigations, your quality unit lacks sufficient information to make reliable decisions on root causes and take effective action," the warning letter says.

Posted 20 September 2017



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