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483
•CCIC Huatongwei International Inspection (Suzhou) Co., Ltd.•January 14, 2025

CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. – FDA 483, Jan 14, 2025

Record Details

The FDA inspected CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., a non-clinical GLP laboratory in Suzhou, China, and found severe deficiencies. The inspection revealed widespread data integrity issues, including photocopied and reused experimental data, inadequate animal identification, and poor archival practices. These findings indicate significant non-compliance with GLP regulations, compromising the reliability and integrity of study results.

Company
CCIC Huatongwei International Inspection (Suzhou) Co., Ltd.
Inspection date
January 14, 2025
Product type
other
Office
Office of Inspections and Investigations
People
  • Tonia F. Bernard
  • Shuliang Li
  • Dawn C. Olenjack
View Company Profile

ID · 6efc7d99-752f-41e8-bf2b-7f8f8337b8d3

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