# FDA 483 - Henan Kangdi Medical Devices Co. Ltd - March 07, 2019

Source: https://www.globalkeysolutions.net/records/483/henan-kangdi-medical-devices-co-ltd/77afab47-0250-4d4b-a4b1-eddfd0e3d351

> FDA 483 for Henan Kangdi Medical Devices Co. Ltd on March 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Henan Kangdi Medical Devices Co. Ltd
- Inspection Date: 2019-03-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Henan Kangdi Medical Devices Co. Ltd, a finished drug product manufacturer in Zhoukou, China, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to perform analytical testing on finished drug products, lacked a meaningful stability program, and accepted components without independent testing. Additionally, issues included inadequate material traceability, uncalibrated equipment, unsecured electronic procedures, and deficient batch production records, indicating severe control issues over drug product quality.

## Related Documents

- [WARNING_LETTER - 2019-03-07](https://www.globalkeysolutions.net/records/warning_letter/henan-kangdi-medical-devices-co-ltd/b1c244ec-7c14-4370-a2a7-b8a61907799c)

## Related Officers

- [Marcellinus D. Dordanou, CSO](https://www.globalkeysolutions.net/people/marcellinus-d-dordanou-cso/2000caed-aca7-4824-9d55-f5251fdb190c)

Company: https://www.globalkeysolutions.net/companies/henan-kangdi-medical-devices-co-ltd/27cc9024-4259-4761-bbf2-9c1bf3ddb827

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