# FDA 483 - Joinn Laboratories Co. Ltd. - May 21, 2024

Source: https://www.keypedia.com/records/483/joinn-laboratories-co-ltd/9ce2b092-f381-4991-b69d-757f36120119

> FDA 483 for Joinn Laboratories Co. Ltd. on May 21, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Joinn Laboratories Co. Ltd.
- Inspection Date: 2024-05-21
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Joinn Laboratories Co. Ltd. in Beijing, China, a nonclinical laboratory, revealed two significant observations. The firm was cited for failing to adequately validate equipment used for data generation and for the quality assurance unit's failure to identify and document deviations from approved protocols.

## Related Officers

- [Deborah A. Greco](https://www.keypedia.com/people/deborah-a-greco/38e393b5-55c4-461c-a0b0-4937e0cbec37)

Company: https://www.keypedia.com/companies/joinn-laboratories-co-ltd/bcb51766-9f7e-4226-a417-5eab0b3d02a1

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1