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

Source: https://www.keypedia.com/records/483/joinn-laboratories-suzhou-co-ltd/8d551c3c-3e96-475f-8abb-552039afd005

> FDA 483 for JOINN Laboratories (Suzhou) Co. Ltd. on May 15, 2026. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: JOINN Laboratories (Suzhou) Co. Ltd.
- Inspection Date: 2026-05-15
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)
- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)
- [Xinguang Li](https://www.keypedia.com/people/xinguang-li/4ffb5467-4a54-4799-93eb-e5958d9d3322)
- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.keypedia.com/companies/joinn-laboratories-suzhou-co-ltd/b85ac76b-adbf-42ef-978e-7e685d2ea68d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4