# FDA 483 - Cheng Fong Chemical Co., Ltd. Dayuan Factory - August 02, 2024

Source: https://www.globalkeysolutions.net/records/483/cheng-fong-chemical-co-ltd-dayuan-factory/9d986c59-9604-47cb-b2c6-91f90d16f219

> FDA 483 for Cheng Fong Chemical Co., Ltd. Dayuan Factory on August 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cheng Fong Chemical Co., Ltd. Dayuan Factory
- Inspection Date: 2024-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cheng Fong Chemical Co., Ltd., a drug manufacturer in Taoyuan City, Taiwan, was inspected and cited for significant deficiencies across its quality systems. The inspection revealed inadequate batch production records, ineffective deviation investigations and corrective actions, insufficient cleaning and maintenance procedures, unverified equipment operational parameters, and improper handling of incoming raw materials and storage conditions. These issues indicate a lack of control over critical manufacturing processes and quality assurance.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/cheng-fong-chemical-co-ltd-dayuan-factory/a22cece7-860c-4a52-9270-2401ec35c6dd

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