# FDA 483 - Sinsin Pharmaceutical Co., Ltd. - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/sinsin-pharmaceutical-co-ltd/b6103018-c4b6-428e-b78e-a6f20e581a31

> FDA 483 for Sinsin Pharmaceutical Co., Ltd. on December 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sinsin Pharmaceutical Co., Ltd.
- Inspection Date: 2019-12-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sinsin Pharmaceutical Co., Ltd. in Ansan-Si, Gyeonggi-Do, Korea, a drug product manufacturer, was cited for significant deficiencies in quality control, data integrity, and equipment cleaning during an FDA inspection. The firm failed to thoroughly investigate discrepancies and complaints, maintain secure electronic data systems, and adequately document equipment cleaning, with some issues being repeat observations. These findings indicate a serious lack of adherence to cGMP regulations.

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## Related Officers

- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

Company: https://www.globalkeysolutions.net/companies/sinsin-pharmaceutical-co-ltd/3d12e29a-e9ed-4ddf-b655-01426b120c0b

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