FDA WARNING_LETTER - CCIC Huatongwei International Inspection Co., Ltd. - January 14, 2025

**FDA Warning Letter Summary: CCIC Huatongwei International Inspection (Suzhou) Co., Ltd.**

**Company Name:** CCIC Huatongwei International Inspection (Suzhou) Co., Ltd.

**Inspection Dates:** January 6, 2025, to January 14, 2025

**Main Violations/Issues:** The FDA inspection revealed significant non-compliance with Good Laboratory Practice (GLP) regulations, specifically under Title 21, CFR Part 58. Key violations include:

1. **Data Integrity Issues:** The study director failed to ensure that experimental data were accurately recorded and verified. Instances were found where source data were photocopied and reused across different studies, compromising data integrity.

2. **Use of Templates:** Templates with pre-completed information were used for final reports, leading to inaccuracies and lack of study-specific data.

3. **Archival Deficiencies:** Required study records were not archived in a timely manner. Modifications to study folders were made shortly before the inspection, indicating potential data manipulation.

**Regulatory Framework:** The inspection was conducted under a program to ensure data validity in submissions for Investigational Device Exemption, Premarket Approval, and Premarket Notification. Compliance with GLP regulations is crucial to assure the quality and integrity of safety data.

**Required Actions:** The FDA requires CCIC Huatongwei to:

- Implement corrective actions to ensure accurate recording and verification of all experimental data. - Cease the use of pre-completed templates and ensure all reports are study-specific. - Establish robust archival practices to ensure timely and complete data retention.

Failure to address these issues could result in regulatory actions, including rejection of data in future submissions. The company must respond with a detailed corrective action plan to address these violations.