On September 6, 2016, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hebei Yuxing Bio-Engineering Co Ltd. This Warning Letter was issued by the US FDA’s Center for Drug Evaluation and Research (CDER) for current Good Manufacturing Practices cGMP violations during manufacture of Active Pharmaceutical Ingredient (API) which resulted in in the API’s being adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetics Act (FD&C Act).
Hebei Yuxing is a firm in China that was inspected between August 17 to 21, 2015. Because of the violations, the firm was placed on Import Detention on July 8, 2016. The violations included
- The quality system does not adequately ensure the accuracy and integrity of data.
- Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures.
- Failure of the quality unit to ensure that all critical deviations are investigated and resolved.
- The quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs