Chinese API Maker Warned for Repeat Violations
The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of validation studies and adequate API analysis.
The agency had observed similar CGMP violations during inspections at the Yicheng Goto facility in 2011 and 2014, and it said the repeated failures show “management’s oversight and control over the manufacture of intermediates and API is inadequate.”
The FDA was not satisfied with the company’s response to the 20 observations in its Sept. 17, 2017 Form 483 report and, on Jan. 10, it placed Yicheng Goto on an import alert for automatic detention of its products at U.S. ports.
In a July 26 warning letter, the agency said the facility failed to conduct cleaning validation studies for the majority of its critical non-dedicated production equipment used to manufacture intermediates and APIs. The staff told the agency investigator there was no requirement to document equipment cleaning between manufacturing runs.
The firm also neglected to run adequate analytical tests for its APIs and it conducted assay and residual solvent testing without performing system suitability tests.
The facility had no ongoing program to monitor process controls.