# FDA 483 - ST Pharm Co., Ltd. - November 08, 2024

Source: https://www.globalkeysolutions.net/records/483/st-pharm-co-ltd/0b2012b9-06d4-479d-a65c-d5bbdbbd4577

> FDA 483 for ST Pharm Co., Ltd. on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ST Pharm Co., Ltd.
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: ST Pharm Co., Ltd., an API manufacturer in Siheung-si, Gyeonggi-do, Korea, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written quality agreements for contract testing and stability studies, inadequate validation of test methods for API purity, and poor document control practices. Additionally, the firm failed to adhere to its own GMP training effectiveness procedures.

## Related Documents

- [483 - 2018-11-05](https://www.globalkeysolutions.net/records/483/st-pharm-co-ltd/9b7e1ff7-022e-457e-b730-29d4e0514a2e)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/st-pharm-co-ltd/fd6521e7-0d83-45a3-ade6-ca4832858cbe

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