# FDA 483 - Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant - August 04, 2023

Source: https://www.globalkeysolutions.net/records/483/teh-seng-pharmaceutical-mfg-co-ltd-3rd-plant/10f46aeb-ff3e-43c9-ae4f-45207e712511

> FDA 483 for Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Teh Seng Pharmaceutical Mfg. Co., Ltd. in Tainan City, Taiwan, revealed two significant observations related to quality control. The firm failed to ensure laboratory controls included scientifically sound standards, specifically regarding the qualification of working standards against primary reference standards. Additionally, investigations into unexplained discrepancies were found to be inadequate, with CAPAs lacking proper documentation for root causes, impact evaluations, and effectiveness processes.

## Related Officers

- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.globalkeysolutions.net/companies/teh-seng-pharmaceutical-mfg-co-ltd-3rd-plant/410dc182-1791-459c-8b4b-afa1aa9fbc49

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