# FDA 483 - Shanghai Henlius Biologics Co., Ltd. - August 01, 2023

Source: https://www.globalkeysolutions.net/records/483/shanghai-henlius-biologics-co-ltd/80493937-1845-4891-b9a3-0375deb27cdd

> FDA 483 for Shanghai Henlius Biologics Co., Ltd. on August 01, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Henlius Biologics Co., Ltd.
- Inspection Date: 2023-08-01
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Shanghai Henlius Biologics Co., Ltd. was inspected from July 26 to August 4, 2023, and received a Form 483 with four observations. The inspection revealed deficiencies in fill line setup procedures, ambient storage area qualifications, facility microbial control, and documentation for a specific test method. These issues indicate a need for improved quality control and procedural adherence.

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## Related Officers

- [Rose Xu](https://www.globalkeysolutions.net/people/rose-xu/60ba3a00-9457-4396-aa6d-ffa374fdb7ae)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/qiong-fu/cb5e715d-7b55-4cf7-873e-62250caa81cf)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.globalkeysolutions.net/companies/shanghai-henlius-biologics-co-ltd/ca560713-8df4-4bed-a460-7157ef410918

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