# FDA 483 - Harbin Jixianglong Biotech Co., Ltd. - November 06, 2025

Source: https://www.keypedia.com/records/483/harbin-jixianglong-biotech-co-ltd/049844ec-c44c-4f5c-bd14-2a77d63ef05f

> FDA 483 for Harbin Jixianglong Biotech Co., Ltd. on November 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harbin Jixianglong Biotech Co., Ltd.
- Inspection Date: 2025-11-06
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Harbin Jixianglong Biotech Co., Ltd. in Harbin, China, an API manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues across quality control, manufacturing processes, data integrity, and documentation, indicating a lack of robust quality systems. These include distributing API without validation, inadequate laboratory controls, poor equipment cleaning, and insufficient computer system controls.

## Related Documents

- [483 - 2025-11-06](https://www.keypedia.com/records/483/harbin-jixianglong-biotech-co-ltd/aa686475-905d-4681-8322-c5bf7aed7de0)
- [WARNING_LETTER - 2025-11-07](https://www.keypedia.com/records/warning_letter/harbin-jixianglong-biotech-co-ltd/5ea22e19-f9b2-4fbb-8a95-67221a484465)

## Related Officers

- [Bijoy Panicker, Investigator](https://www.keypedia.com/people/bijoy-panicker-investigator/f4f6d98e-8cac-4c4b-a686-3dfbee6af7d4)
- [Tekalign Wondimu, Investigator](https://www.keypedia.com/people/tekalign-wondimu-investigator/1b4fa1e4-dcc0-4a64-961e-f7d878c457c0)

Company: https://www.keypedia.com/companies/harbin-jixianglong-biotech-co-ltd/b80f231a-2af4-453b-ad8d-0f27575c586a

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3