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483
•JOINN Laboratories (Suzhou)•May 15, 2026

JOINN Laboratories (Suzhou) – FDA 483, May 15, 2026

Record Details

An FDA inspection of JOINN Laboratories (Suzhou) Co. Ltd., a non-clinical laboratory, revealed significant deficiencies across two observations. Issues included personnel failing to understand their functions, leading to poor record-keeping, mislabeled samples and reagents, and improper equipment calibration. Additionally, the facility's physical structure was found unsuitable, with problems such as inadequate drainage in animal rooms and faulty door mechanisms.

Company
JOINN Laboratories (Suzhou)
Inspection date
May 15, 2026
Product type
other
Office
Office of Medical Device and Radiological Health Operations
People
  • Julian C. Hanson
  • Andrew R. Wasko
  • Xinguang Li
  • Lakecha N. Lewis (Business Analyst/Provider Enrollment Specialist)
View Company Profile

ID · 8d551c3c-3e96-475f-8abb-552039afd005

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