# FDA 483 - Sinsin Pharmaceutical Co., Ltd. - February 14, 2025

Source: https://www.keypedia.com/records/483/sinsin-pharmaceutical-co-ltd/09afed3c-6fd0-46b6-acb8-ff5ecac5df45

> FDA 483 for Sinsin Pharmaceutical Co., Ltd. on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sinsin Pharmaceutical Co., Ltd.
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sinsin Pharmaceutical Co., Ltd. in Sejong, Korea, a drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate investigations into discrepancies and complaints, failure to follow stability testing programs, lack of component identity verification, and issues with equipment calibration and facility design. These findings indicate a serious lack of control over manufacturing processes and quality assurance.

## Related Documents

- [483 - 2019-12-13](https://www.keypedia.com/records/483/sinsin-pharmaceutical-co-ltd/b6103018-c4b6-428e-b78e-a6f20e581a31)
- [WARNING_LETTER - 2025-04-15](https://www.keypedia.com/records/warning_letter/sinsin-pharmaceutical-co-ltd/f8734ffe-53c2-427e-a757-6ccb7ee68dc6)

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8