# FDA 483 - Dongying Tiandong Pharmaceutical Co Ltd - October 19, 2018

Source: https://www.globalkeysolutions.net/records/483/dongying-tiandong-pharmaceutical-co-ltd/b7fc1349-bd33-4c02-b727-dafae6955a0b

> FDA 483 for Dongying Tiandong Pharmaceutical Co Ltd on October 19, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dongying Tiandong Pharmaceutical Co Ltd
- Inspection Date: 2018-10-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Dongying Tiandong Pharmaceutical Co., Ltd., an API manufacturer in Dongying, China, revealed significant deficiencies in documentation and laboratory control. The firm failed to maintain adequate records for crude material supplier traceability and lacked complete laboratory control records, including raw data for real-time PCR assay validations. These issues indicate a lack of robust quality system controls.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/dongying-tiandong-pharmaceutical-co-ltd/77a4377c-a6ef-4d13-aa11-0ff3e02ed254

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