# FDA 483 - Xinyu Pharmaceutical Co., Ltd. - March 11, 2019

Source: https://www.globalkeysolutions.net/records/483/xinyu-pharmaceutical-co-ltd/0e6760db-5d5a-4439-85e6-9adc6f471c6a

> FDA 483 for Xinyu Pharmaceutical Co., Ltd. on March 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xinyu Pharmaceutical Co., Ltd.
- Inspection Date: 2019-03-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Xinyu Pharmaceutical Co., Ltd. in Suzhou, China, was inspected from March 11-15, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate change control for API quality, insufficient documentation practices for stability data, and a deficient system for maintaining and calibrating critical equipment. Additionally, the validation of GMP-related computerized systems was found to be inadequate.

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## Related Officers

- [Marijo B. Kambere](https://www.globalkeysolutions.net/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.globalkeysolutions.net/companies/xinyu-pharmaceutical-co-ltd/f603cb84-26a5-448f-9d9d-c25547afa6b7

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb