Korean drugmaker used employees to test potentially harmful ointment, FDA says
- The Food and Drug Administration has warned an Asian drugmaker for using faulty procedures that the agency claims violate current good manufacturing practices, including testing possibly harmful products on its employees.
- Korea-based Firson Co. Ltd.'s faced a handful of criticisms in an FDA warning letter dated Aug. 31, chief among them being it didn't properly investigate customer complaints. The company received 32 complaints in 2016, including some related to ointment it produced that customers said caused burning, irritation, pain and other side effects.
Though Firson opened investigations into those issues, the FDA found them not only inadequate, but also highlighted their questionable tactics. "Each of your investigations consisted of testing 'storage samples' and applying drug product from at least three implicated complaint lots on your employees as “test subjects," the agency noted.
The FDA inspected Firson's facility from Nov. 3 to Nov. 11 of last year. In general, the plant suffers from many of the same problems the agency has found at other production centers in Asia.
For instance, Firson didn't have effective procedures in place for sterilizing drugs or testing the chemical structure of compounds used in product development.
"You lacked assurance that in-process materials and finished drug products met predetermined manufacturing and quality requirements," the FDA said in its warning letter. "The purpose of validation is to determine whether your processes can operate within established parameters to assure consistent batch uniformity, integrity, and drug quality. Reliable and well-documented batch operations are essential to ensuring process control and drug quality."
The most egregious violations, however, appeared tied to oversight. In particular, the agency concluded Firson's internal investigations lacked depth and ability to get to the core of manufacturing problems.
"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 FDA said.
Firson was placed on the FDA's import ban list on May 11.
In addition to Firson, regulators recently issued a warning letter to China-based Wuxi Medical Instrument Factory.
Based on a March 6 to March 10 inspection of the drugmaker's site in the Jiangsu province, the FDA found that, like Firson, there were issues with Wuxi's procedures and recordkeeping for sterilizing drugs and manufacturing equipment.
"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 FDA wrote in its warning letter to Wuxi.
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