FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - January 06, 2025

**FDA 483 Summary for Executives: Suzhou Suncadia Biopharmaceuticals Co. Ltd.**

**Inspection Dates:** December 30, 2024 - January 6, 2025 **Location:** Suzhou, Jiangsu Province, China **Facility Type:** Drug substance and drug manufacturer

**Key Observations:**

1. **Microbiological Contamination Prevention:** The facility"s procedures to prevent microbiological contamination in sterile drug products are inadequate. The media fill program does not accurately simulate aseptic operations, with discrepancies in operator numbers and line speeds. Environmental monitoring is insufficient, lacking comprehensive air and surface monitoring during critical operations. Additionally, aseptic processing systems have design flaws that could lead to contamination.

2. **Visual Inspection Procedures:** The visual inspection process lacks thoroughness, with inappropriate testing kits that do not reflect actual product conditions. This raises concerns about the reliability of quality assurance measures.

3. **Equipment Calibration and Validation:** Automatic and electronic equipment, including software systems, are not routinely calibrated or validated. Notably, software settings for non-viable particle monitoring systems were not verified post-upgrade, and SCADA software validation is inadequately documented.

**Regulatory Framework:** The observations fall under the FDA"s regulatory oversight for ensuring drug manufacturing compliance with Good Manufacturing Practices (GMP).

**Required Actions:** Suzhou Suncadia Biopharmaceuticals must address these deficiencies by enhancing their aseptic process simulations, improving environmental monitoring protocols, ensuring comprehensive visual inspection procedures, and implementing routine calibration and validation of electronic systems. Immediate corrective actions and a detailed response plan should be submitted to the FDA to demonstrate compliance and prevent potential enforcement actions.