# FDA 483 - Huilai Tianjin Zhang - February 21, 2025

Source: https://www.globalkeysolutions.net/records/483/huilai-tianjin-zhang/a8d9623d-a869-408f-8662-49936f6ba7d6

> FDA 483 for Huilai Tianjin Zhang on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huilai Tianjin Zhang
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hailai Zhang, MD, a clinical investigator in Tianjin, China, revealed significant failures to follow the investigational plan. Observations included delayed reporting of serious adverse events (SAE) and adverse events of special interest (AESI) to the sponsor, as well as incorrect administration of study medication dosages to multiple subjects. These findings indicate critical deviations from protocol requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.globalkeysolutions.net/companies/huilai-tianjin-zhang/c1d18b95-d4b5-46eb-8e19-322bb427392b

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8