FDA 483 - Jiangsu Intco Medical Products Co., Ltd. - November 17, 2023

From November 13 to November 17, 2023, the FDA inspected the facility of Jiangsu Intco Medical Products Co., Ltd., an over-the-counter (OTC) drug manufacturer located in Zhenjiang, China. The resulting FDA Form 483 identifies several critical failures in the company’s adherence to Current Good Manufacturing Practice (CGMP) standards.

A primary concern is the firm"s failure to maintain essential documentation; the company reportedly destroyed batch production records that were necessary to support process validation and stability studies for OTC liquids and gels. Furthermore, the laboratory testing program was found to be deficient because the company did not conduct stability testing for all marketed packaging sizes, meaning certain products lacked data to verify their expiration dates.

The inspection also uncovered weaknesses in the materials management system. The facility failed to perform specific identity tests on drug components and did not adequately validate the information provided on supplier certificates of analysis. By qualifying suppliers without conducting full testing required by the United States Pharmacopeia (USP), the company could not guarantee the quality and purity of its raw materials.

Jiangsu Intco Medical Products must address these observations by submitting a comprehensive corrective action plan to the FDA. While these observations represent preliminary findings rather than a final agency determination, they highlight systemic issues that require immediate remediation to ensure product safety and regulatory compliance.