Chengdu Records Review Finds CGMP Deviations

An FDA review of records supplied by Chengdu Innovation Pharmaceutical Co. in Sichuan Sheng, China, following an agency 4/29/2024 request, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/5 Warning Letter says specific deviations were:

• failure to test the identity of each lot of incoming production material; and
• failure of the firm’s quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.

FDA recommends that Chengdu engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed the firm’s products on a 1/17 Import Alert.

Chengdu was told to correct any deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.