ST Pharm Co., Ltd.November 8, 2024

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

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Record Details

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.

Company: ST Pharm Co., Ltd.
Inspection Date: November 8, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Rajiv R. Srivastava (Consumer Safety Officer)

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