# FDA 483 - Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd - August 18, 2023

Source: https://www.keypedia.com/records/483/hangzhou-zhongmei-huadong-pharmaceutical-co-ltd/17808756-e58b-4c57-a0bc-a7e9d8f336ef

> FDA 483 for Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd on August 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
- Inspection Date: 2023-08-18
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd was cited for significant deficiencies during an FDA inspection of its sterile drug manufacturing operations. Observations included inadequate procedures for preventing microbiological contamination during aseptic filling, insufficient validation of the aseptic process, and a deficient quality control unit regarding visual inspection speeds. Additionally, the firm lacked appropriate computer system controls to prevent unauthorized data modification in laboratory systems.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/hangzhou-zhongmei-huadong-pharmaceutical-co-ltd/484385fe-e88b-4fbd-a58d-4759ca816ab9

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c