Zhejiang Huahai Pharmaceutical Co., Ltd. – FDA 483, Apr 16, 2025

**FDA 483 Summary for Zhejiang Huahai Pharmaceutical Co., Ltd.**

**Inspection Dates:** January 16-17, and 20-24, 2025 **Location:** Linhai, Zhejiang, China **Facility Type:** Drug Manufacturer

**Key Violations/Issues:**

1. **Inadequate Cleaning Procedures:** - Equipment and utensils were not cleaned effectively, leading to potential contamination risks. Observations included visible residues on equipment surfaces, valves, and ducts, which were not identified or adequately addressed before production. This issue was noted across multiple pieces of equipment used for manufacturing products for the US market.

2. **Insufficient Cleaning Validation:** - The cleaning validation studies failed to identify the most challenging areas to clean, such as gaskets and product surfaces. Sampling was limited and did not cover all critical areas, potentially compromising the cleaning effectiveness.

3. **Inadequate Sterilization Process Validation:** - Procedures to prevent microbiological contamination in sterile drug products were found lacking. Smoke studies, which assess airflow and contamination control, were incomplete. Key interventions and dynamic conditions during aseptic processing were not thoroughly evaluated, potentially impacting product sterility.

**Regulatory Framework:** The observations are based on FDA regulations that require drug manufacturers to maintain strict standards for equipment cleanliness and sterilization processes to ensure product safety, identity, strength, quality, and purity.

**Required Actions:** Zhejiang Huahai Pharmaceutical Co., Ltd. must address these observations by implementing corrective actions. This includes revising cleaning and validation procedures, ensuring comprehensive evaluation of all equipment areas, and enhancing smoke studies to fully assess aseptic processing conditions. The company is encouraged to discuss objections or corrective actions with FDA representatives and submit detailed plans for compliance improvements.