# FDA 483 - Joinn Laboratories Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/joinn-laboratories-co-ltd/8fdd71ed-5b9f-4575-897e-c63f800f0ac7

> FDA 483 for Joinn Laboratories Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joinn Laboratories Co., Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Joinn Laboratories Co., Ltd. in Beijing, China, a Good Laboratory Practice facility, revealed significant deficiencies in quality assurance, study protocol adherence, and data management. Observations included failures to accurately reflect raw data in final reports, ensure protocol approval and follow-through, and properly archive study records. These issues indicate a lack of robust controls over the integrity and reliability of study data.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [investigator](https://www.globalkeysolutions.net/people/niraj-r-mehta/301b1292-47a7-4535-9711-10e001a15ef8)
- [Francis J. Eng](https://www.globalkeysolutions.net/people/francis-j-eng/dc9b589d-9a55-4912-8a06-6d34226225ab)

Company: https://www.globalkeysolutions.net/companies/joinn-laboratories-co-ltd/e40c469a-5862-47b3-9c96-c4f8b0bc7c1a

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd