# Zhejiang Huahai Pharmaceutical – FDA 483, Aug 3, 2018

Source: https://www.keypedia.com/records/483/zhejiang-huahai-pharmaceutical/52b9509e-bd30-4536-a4de-b2064ff256b1

> FDA 483 for Zhejiang Huahai Pharmaceutical on August 03, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zhejiang Huahai Pharmaceutical
- Inspection Date: 2018-08-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. revealed significant deficiencies across its quality, production, and laboratory systems. The firm demonstrated inadequate change control, insufficient process and cleaning validation, and poor deviation investigation practices. These issues indicate a systemic failure to ensure the quality and purity of Active Pharmaceutical Ingredients (APIs) manufactured at the facility.

## Related Documents

- [483 - 2024-11-12](https://www.keypedia.com/records/483/zhejiang-huahai-pharmaceutical/0d625237-e9c9-461e-8eb0-a847ea9ec569) — date: November 12, 2024
- [EIR - 2018-08-03](https://www.keypedia.com/records/eir/zhejiang-huahai-pharmaceutical/bb2ccf9a-46df-46ac-8325-37fe8731ef0b) — date: August 3, 2018
- [EIR - 2017-05-19](https://www.keypedia.com/records/eir/zhejiang-huahai-pharmaceutical/4f117789-6333-46f2-825b-833001cf712d) — date: May 19, 2017
- [483 - 2017-05-19](https://www.keypedia.com/records/483/zhejiang-huahai-pharmaceutical/10ed9d01-4251-4c68-ae3d-2b6fc630a940) — date: May 19, 2017

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)
- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.keypedia.com/companies/zhejiang-huahai-pharmaceutical/7742a83d-0a0c-4aed-9039-0b8b928ce70f

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