Drugs

CGMP Violations at China’s Dongying Tiandong

David McFarland

— 1 min read
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A 10/12-16/15 FDA inspection at Dongying Tiandong Pharmaceutical Co., Shandong, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/10 Warning Letter. Specific deviations included: 

  •          failing to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions;
  •          failing to ensure that test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity;
  •          failing to adequately monitor crude heparin suppliers; and
  •          failing to have the firm’s quality unit ensure that all critical deviations are investigated and resolved.

The company was told to respond with a list of steps it has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completing the steps.

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