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Firm in China Must Resolve All FDA Concerns to Resume Exporting API to U.S.

This article was originally published in The Gold Sheet

Executive Summary

Kunshan Chemical and Pharmaceutical Co. of Kunshan City, China, has corrected or begun to correct many of the deficiencies cited in a Sept. 6 warning letter from FDA. However, until it remedies all outstanding deficiencies, including problems with documentation of batch production records and method validation, lab equipment calibration and production equipment cleaning and maintenance, "any future shipments of APIs manufactured at the Kun Tai Road site (Old Site) will be denied entry into the United States," Richard Friedman, director of the Division of Manufacturing and Product Quality in CDER's Office of Compliance, said in the letter, which was based on an April 2007 inspection of that site and the new Provincial Highway site. Kunshan said it was not shipping API from the old site to the U.S., but FDA had information to the contrary
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