# FDA 483 - Excellence Medical Supplies Co., Ltd. - July 12, 2019

Source: https://www.globalkeysolutions.net/records/483/excellence-medical-supplies-co-ltd/81fa8258-c1af-4a6a-a29c-33c27c66c69d

> FDA 483 for Excellence Medical Supplies Co., Ltd. on July 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Excellence Medical Supplies Co., Ltd.
- Inspection Date: 2019-07-12
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jiangsu Excellence Medical Supplies Co., Ltd, a combination product and device manufacturer, revealed significant deficiencies. Observations included inadequate stability programs, insufficient laboratory controls for product testing, pest infestation in the warehouse, and failure to properly qualify component suppliers. These issues indicate a lack of robust quality control and manufacturing practices.

## Related Officers

- [Laurimer Kuulan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuulan-torres/c9c7d245-50a9-427b-962f-a50f00d7ada7)

Company: https://www.globalkeysolutions.net/companies/excellence-medical-supplies-co-ltd/dff487e4-2f10-49d8-96a7-6937e7a1305d

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