# FDA 483 - Guangzhou Tinci Materials Technology Co., Ltd. - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/guangzhou-tinci-materials-technology-co-ltd/7a500198-3389-4cdf-8211-0375452cc0d5

> FDA 483 for Guangzhou Tinci Materials Technology Co., Ltd. on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangzhou Tinci Materials Technology Co., Ltd.
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Guangzhou Tinci Materials Technology Co., Ltd. received a Form 483 following an inspection that identified significant deficiencies across its manufacturing and quality systems. Observations included inadequate environmental controls, lack of proper equipment design documentation, and failures in microbial control procedures. Additionally, the firm was cited for not establishing production time limits, a quality unit that failed to investigate significant deviations, and inadequate laboratory data controls, indicating a broad lack of adherence to cGMP requirements for drug product manufacturing.

## Related Officers

- [Cheryl A. Clausen](https://www.globalkeysolutions.net/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.globalkeysolutions.net/companies/guangzhou-tinci-materials-technology-co-ltd/d40928c2-c69a-41bf-b645-af8498e75875

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