Chinese API supplier warned by FDA over manipulated data
pharmafile | March 12, 2010 | News story | Manufacturing and Production |Â Â API, China, XiAn Libang Pharmaceutical, manufacturing qualityÂ
A Chinese manufacturer has been sent a warning letter by the US Food and Drug Administration after it emerged an employee manipulated testing data on incoming raw materials used in the production of active pharmaceutical ingredients.
The company, XiAn Libang Pharmaceutical, supplies APIs to the US, Europe and other markets around the world from a 3,000 sq. m. facility based in the Xian Hi Tech Zone in ShanXi, central China.
APIs shipped from the facility into the US market include the antiemetic drug droperidol, diuretic metolazone, the local anaesthetic ropivacaine, muscle relaxant suxamethonium chloride, respiratory stimulant doxapram HCl, and amlodipine maleate for high blood pressure.
The warning letter details a number of failings of the company’s quality department, including the use of ‘inappropriate’ and ‘unacceptable’ testing methods and inadequate record-keeping.
Most seriously, the company failed to detect that infrared spectra tests were being substituted by an employee at the company and did not do enough to make sure this was an isolated incident, said the agency.
The chemist responsible for the substitution has been fired, while the managers responsible for overseeing the work have been removed from the quality management team, according to XiAn Libang Pharmaceutical.
However, “a cursory review of records is not sufficient to ensure that other personnel did not manipulate or inaccurately report test data”, writes Richard Friedman, director of manufacturing and product quality at the FDA’s Center for Drug Evaluation and Research, in the letter.
The FDA inspected the facility in July 2009 and received a response from the company the following September, but the company’s investigation into the matter was not comprehensive, according to the US agency.
It recommends that XiAn Libang Pharmaceutical hires a third-party auditor to help it to compile a new Corrective Action Plan, and has given the company a 15-day deadline to respond to its concerns or face an import ban on its APIs into the US.
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