# FDA 483 - Jiangsu Intco Medical Products Co., Ltd. - November 17, 2023

Source: https://www.keypedia.com/records/483/jiangsu-intco-medical-products-co-ltd/a60521d7-f824-448b-a6ea-48412035e1ab

> FDA 483 for Jiangsu Intco Medical Products Co., Ltd. on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Intco Medical Products Co., Ltd.
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Jiangsu Intco Medical Products Co., Ltd., an OTC drug manufacturer in Zhenjiang, China, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate production and process controls, including failure to retain process validation records and maintain a robust stability testing program. Additionally, the firm was cited for insufficient drug product component testing and a deficient supplier qualification program.

## Related Documents

- [483 - 2023-11-17](https://www.keypedia.com/records/483/jiangsu-intco-medical-products-co-ltd/ee9c310b-c49b-4c8c-a307-b15985dd37c7)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.keypedia.com/companies/jiangsu-intco-medical-products-co-ltd/6f92583c-b16a-449e-8cdf-cc9f687340de

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c