FDA WARNING_LETTER - Innova - January 17, 2025

The FDA issued Warning Letter 320-25-40 to Chengdu Innovation Pharmaceutical Co., Ltd. (FEI 3027222600) on February 5, 2025, following a review of records submitted in response to an April 29, 2024, Section 704(a)(4) request. The facility, registered as an API manufacturer, was found to have significant deviations from Current Good Manufacturing Practice (CGMP), rendering its APIs adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to test the identity of each lot of incoming production material:** The company admitted not performing identity testing on each shipment of incoming materials before release for drug manufacturing, lacking scientific evidence of material conformity to specifications. 2. **Failure of the quality unit (QU) to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials:** The QU did not effectively oversee drug manufacturing quality, specifically failing to establish an appropriate system for approving or rejecting incoming materials, which is crucial for consistent drug quality per ICH Q7 guidance.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and assess corrective actions. The company's products were placed on Import Alert 66-40 on January 17,