# FDA 483 - Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) - March 22, 2019

Source: https://www.keypedia.com/records/483/zhejiang-kangle-pharmaceutical-co-ltd-binhai-plant/39f6750c-499f-4041-a4d2-0acaa910a734

> FDA 483 for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Kangle Pharmaceutical Co Ltd, a finished dose intermediate manufacturer in Wenzhou, Zhejiang, PRC, revealed significant deficiencies. Observations included failures in securing and controlling cleaning documents, inadequate cleaning procedures and documentation, and a lack of proper training for production employees on deviation reporting. These issues suggest a concerning lack of adherence to established quality control protocols.

## Related Officers

- [Senior Director Technical](https://www.keypedia.com/people/christopher-t-middendorf/0fea23f5-ffe6-49a0-ac33-780317707c71)

Company: https://www.keypedia.com/companies/zhejiang-kangle-pharmaceutical-co-ltd-binhai-plant/13be9174-238f-43cf-bdf4-0c57cc0b0bc2

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