# FDA 483 - Shenzhen Oriental Pharmaceutical Co Ltd - January 07, 2019

Source: https://www.keypedia.com/records/483/shenzhen-oriental-pharmaceutical-co-ltd/17c7343e-7e99-44ef-8c81-517170bd7508

> FDA 483 for Shenzhen Oriental Pharmaceutical Co Ltd on January 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shenzhen Oriental Pharmaceutical Co Ltd
- Inspection Date: 2019-01-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shenzhen Oriental Pharmaceutical Co., Ltd., an API manufacturer in Longgang District, Shenzhen, China, was cited with four observations during an FDA inspection. The inspection revealed significant issues with out-of-specification investigations, lack of Quality Assurance preapproval for testing protocols, unexplained deviations in annual product reviews, and concerns regarding valve and piping connections in cleanroom production areas. These findings indicate deficiencies in quality control and manufacturing processes.

## Related Documents

- [EIR - 2024-11-29](https://www.keypedia.com/records/eir/shenzhen-oriental-pharmaceutical-co-ltd/f3ecf4dd-c30b-4eb7-903e-af7eff82a0eb)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/shenzhen-oriental-pharmaceutical-co-ltd/71227651-964f-4f33-a24b-5c0b0f6c92a0

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