This warning letter is regarding the FDA July 27-30, 2009 inspection of the API manufacturing facility Xian Liang Pharmaceutical located at Shanxi, China. The inspection identified significant deviations from the Current Good Manufacturing Practice (CGMP) for the manufacture of APIs.

The letter informs that specific deviations observed during the inspection include, but are not limited, to:

1. Failure of Xian Libang’s quality unit to ensure that materials are appropriately tested and the results are reported. “Your firm used the IR [infrared] spectra for one lot to approve and release two subsequent incoming lots,” it says.

2. Failure of Xian Libang’s quality unit to exercise its responsibility to ensure the APIs manufactured at their facility are in compliance with CGMP, and meet established specifications for quality and purity. “Your quality control unit failed to detect that IR spectra were being substituted by a laboratory employee and therefore, misrepresenting the actual results of the tested incoming material. Your response is inadequate in that it does not address the ability of your quality unit to control and detect the manipulation or alteration of Laboratory documents,” it says.

3. Failure of Xian Libang to have adequate controls to prevent manipulation of raw data during routine analytical testing. “Your firm's laboratory analyst had modified printed raw data related to an IR Spectra test,” it says.

The letter warns that “in addition to evaluating and correcting these data integrity concerns, we recommend that you conduct a complete and extensive evaluation of your overall quality and manufacturing controls to ensure that APIs manufactured at your facility meet the quality and purity characteristics that they purport to possess”.

The deviations cited in the FDA letter are not intended to be an all-inclusive statement of deviations that exist at Xian Libang’s facility. “You are responsible for investigating and determining the causes of the deviations identified above and for preventing the recurrence of these deviations and the occurrence of other deviations. If you wish to continue to ship APIs to the US, it is the responsibility of your firm to ensure compliance with all US standards for CGMP and all applicable US laws and regulations,” it is stated in the FDA warning letter.

References:

Chinese API Supplier Cited for Not Detecting Altered Data. FDA News Drug GMP Report March 2010.

FDA Warning Letter. 2010 January 28.