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483
•Shanghai Henlius Biologics Co., Ltd.•August 1, 2023

Shanghai Henlius Biologics Co., Ltd. – FDA 483, Aug 1, 2023

Record Details

Shanghai Henlius Biologics Co., Ltd. was inspected from July 26 to August 4, 2023, and received a Form 483 with four observations. The inspection revealed deficiencies in fill line setup procedures, ambient storage area qualifications, facility microbial control, and documentation for a specific test method. These issues indicate a need for improved quality control and procedural adherence.

Company
Shanghai Henlius Biologics Co., Ltd.
Inspection date
August 1, 2023
Product type
biologics
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People
  • Rose Xu
  • Qiong Fu (FDA_PERSONNEL)
  • Michael R. Shanks (Investigator)
  • Ruo (Rose) H. Xu (Sr. Pharmaceutical Quality Scientist)
View Company Profile

ID · 80493937-1845-4891-b9a3-0375deb27cdd

Other documents for Shanghai Henlius Biologics Co., Ltd.
  • 483 - 2025-03-11March 11, 2025
  • EIR - 2025-03-11March 11, 2025
  • 483 - 2025-01-24January 24, 2025
  • 483 - 2025-01-24January 24, 2025

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