# FDA 483 - Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/hangzhou-zhongmeihuadong-pharmaceutical-jiangdong-co-ltd/8809b5ab-40a0-4f71-96fe-261998feaa8e

> FDA 483 for Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co. Ltd, an Active Pharmaceutical Ingredient Manufacturer, an observation was made regarding the firm's quality unit procedures. Specifically, the firm failed to follow its own change control SOP by not initiating a change control for a specified test in a finished product validation test method. This indicates a lapse in adherence to established quality management processes.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/hangzhou-zhongmeihuadong-pharmaceutical-jiangdong-co-ltd/a849e5dc-0723-4fe8-9485-5440caae744b

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