# FDA 483 - Guang'an Kingday Pharma & Chem Co. Ltd. - May 20, 2024

Source: https://www.globalkeysolutions.net/records/483/guangan-kingday-pharma-chem-co-ltd/acc4f66b-c074-4e5b-85a3-d4019b0c9c1c

> FDA 483 for Guang'an Kingday Pharma & Chem Co. Ltd. on May 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guang'an Kingday Pharma & Chem Co. Ltd.
- Inspection Date: 2024-05-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Guang'An Kingday Pharma & Chem Co. Ltd., an API manufacturer in Guang'An, China, revealed significant deficiencies in quality control. Observations included inadequate monitoring of the water system for objectionable microorganisms, insufficient controls for computerized inventory systems, and a failure to routinely monitor cleaning procedures after initial validation. These issues indicate a lack of robust quality assurance practices.

## Related Officers

- [Dorothy P. Kramer](https://www.globalkeysolutions.net/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/guangan-kingday-pharma-chem-co-ltd/eca87ccc-31bd-4b21-8265-be4fac83d6bf

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