FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - December 14, 2023

From November 30 to December 14, 2023, the FDA inspected Suzhou Suncadia Biopharmaceuticals Co., Ltd. in Suzhou, Jiangsu, China, a manufacturer of drug substance and drug product. The inspection identified ten observations related to quality system and manufacturing deficiencies.

**Key Observations:**

1. **Aseptic Processing Issues:** The drug product manufacturing process involves frequent high-risk interventions to aseptic processing (HRIAP) in the vial fill line. This includes operators and large carts crossing Grade A laminar flow areas, requiring manual dismantling and reassembly of equipment. Decontamination after HRIAP is inadequate, lacking sporicidal agent use on affected areas and equipment. Documentation of HRIAP events is insufficient, with operator crossings not individually counted or limited during setup. Complementary data to support HRIAP is lacking, including smoke studies for cart movement and personnel crossings, absence of non-viable particle probes, and no shoe cap testing for microbial contamination.

2. **Data Integrity and System Access:** * Manual integration of IEC-HPLC peak areas is routinely performed despite automated integration, with significant differences (≥5%) between methods, and the SOP lacks adequate instructions for manual integration. * QC testing systems, such as a pH meter, lacked user and password protection, rendering critical data unattributable, contradicting the firm's Data Integrity policy. * Raw electronic data from standalone pH meters used for