Warning Letter Says Chinese Firm Must Comply With Remediation or Face Import Ban

Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it doesn’t correct multiple deficiencies cited in a scathing 483 inspection report, according to a warning letter issued earlier this month.

“FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed,” the letter said, adding “Failure to address any deviations may also result in the FDA refusing admission of articles” manufactured at the plant in Guanghan, Sichuan.

The 483 found that the plant had virtually no quality control documentation, no records of quality testing for drugs shipped to the U.S., and a pattern of retesting out-of-specification (OOS) materials until achieving an acceptable result.

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