JOINN Laboratories (Suzhou) Co. Ltd.May 15, 2026

FDA 483 - JOINN Laboratories (Suzhou) Co. Ltd. - May 15, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore JOINN Laboratories (Suzhou) Co. Ltd.

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) Co. Ltd.
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)

Open in Dashboard

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