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

The FDA conducted an inspection of ST Pharm Co., Ltd., an API manufacturer located in Gyeonggi-do, Korea, from November 4 to November 8, 2024. The inspection revealed several compliance issues primarily related to Good Manufacturing Practices (GMP).

Key observations included the absence of a formal quality agreement between ST Pharm's Sihwa and Banwol sites, which is necessary to clearly define GMP responsibilities. Additionally, the company lacked a quality agreement with a third-party laboratory responsible for conducting stability studies, which is a critical component of ensuring product quality.

The inspection also identified deficiencies in test procedures. Specifically, the in-house test method for analyzing an API's purity was not validated for certain impurities, potentially compromising the accuracy of test results. Furthermore, document management practices were found lacking, as there was no reconciliation of issued worksheets, and shredded documents were not properly logged, raising concerns about unauthorized use or disposal.

Another significant issue was the ineffective training of employees in CGMP practices. The company's training procedures were not consistently followed, with several instances where employees were deemed adequately trained despite scoring below the required threshold on assessments.

The FDA requires ST Pharm to address these issues by establishing comprehensive quality agreements, validating test methods, improving document control, and ensuring effective employee training. These corrective actions are essential to comply with regulatory standards and ensure the quality and safety of their pharmaceutical products.