FDA 483 - Ningbo Shuangcheng Pharmaceutical Co., Ltd. - November 03, 2023

During an inspection by the U.S. Food and Drug Administration (FDA) from October 30 to November 3, 2023, Ningbo Shuangcheng Pharmaceutical Co., Ltd., a manufacturer based in Ningbo, China, was issued an FDA Form 483 detailing two key observations. The primary regulatory framework for these observations relates to current Good Manufacturing Practices (GMPs).

The first significant issue identified was a deficiency within the firm's quality control unit. It was observed that this unit lacked the responsibility to formally approve all procedures or specifications that could impact the identity, strength, quality, and purity of drug products. Specifically, the company's change control procedure did not require a formal assessment for revisions to critical documents, such as manufacturing batch records, thus failing to adequately evaluate potential impacts of such changes.

The second major observation highlighted inadequate cleaning practices for equipment and utensils. An FDA investigator noted visible white residue on the primary packaging line equipment designated for tablets, despite a recent cleaning. Initial attempts to remove the residue with a dry cloth were ineffective, indicating that the firm's cleaning procedures or their execution were insufficient to prevent potential product contamination. The residue was only removed when a wet cloth was applied, as outlined in the proper procedure.

As a result of these observations, Ningbo Shuangcheng Pharmaceutical Co., Ltd. is required to address these findings by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and maintain drug product quality and safety.