The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu KeCheng Fine Chemicals Co., Ltd earlier this month, following the company’s repeated failure to respond to the agency’s attempts to establish contact. The warning was prompted by the company’s avoidance of follow-up communications and its refusal to provide information for the CDE’s records.
KeCheng’s FDA Registration and US Market Shipments
KeCheng, registered with the FDA as a manufacturer of several active pharmaceutical ingredients (APIs), has shipped multiple consignments to the US market. From July 2022, the FDA initiated electronic requests and telephone calls to the company for additional records and information, all of which went unanswered until an October 2022 phone call. During this call, a company representative refused to provide further details or an alternative email address, stating that the company would deregister as a drug firm for US import purposes.
Continued API Shipments and FDA’s Response
Despite the company’s statement, API shipments continued, and the FDA made another electronic attempt to connect with KeCheng in March 2023, which was also ignored. As a result, all drugs and drug products manufactured by KeCheng have been placed on Import Alert until the company’s compliance with Good Manufacturing Practice (GMP) standards can be confirmed by the FDA.-Fineline Info & Tech
