# FDA 483 - Pharmadax (Foshan) Co., Ltd (Heshun Plant) - March 11, 2019

Source: https://www.keypedia.com/records/483/pharmadax-foshan-co-ltd-heshun-plant/3e1ada08-4450-4379-9821-088e8b0617ce

> FDA 483 for Pharmadax (Foshan) Co., Ltd (Heshun Plant) on March 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmadax (Foshan) Co., Ltd (Heshun Plant)
- Inspection Date: 2019-03-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pharmadax (Foshan) Co., Ltd (Heshun Plant) in Foshan City, China, was cited during a Preapproval Inspection for its drug product manufacturing operations. Observations included deficiencies in equipment qualification, lack of final reports for validation/verification activities, and inadequate second-person verification of laboratory records. These issues indicate a need for improved quality system controls to ensure product quality and data integrity.

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/pharmadax-foshan-co-ltd-heshun-plant/8d5926fd-deba-4359-a501-175e1cfeb674

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