The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination.
In a July inspection, the agency found that the firm demonstrated an “unacceptably high risk” of cross-contamination among ingredients at the facility. The company failed to use separate facilities during the manufacturing process and repackaged ingredients in the same room with non-dedicated equipment, risking cross-contamination of ingredients that could initiate life-threatening or other drug-induced reactions in patients.
The company said it would continue to use non-dedicated facilities and eventually handle, repack and relabel ingredients in the area, cleaning before and after. But the FDA was not satisfied with this response, stating that “cleaning cannot substitute for proper segregation” and reminding the firm that all manufacturing should be done in dedicated, separate facilities with separate air handling systems and production equipment.
The agency recommended the firm assess if ingredients packaged by the facility could have contaminated each other, noting that tests for detecting contamination are limited in their reliability due to sample size and method limitations.
The firm also failed to keep batch repackaging records, and its quality unit lacked written procedures for API repackaging, approval and release.