FDA 483 - Shandong New Time Pharmaceutical Co. Ltd. - July 09, 2024

During an inspection conducted from July 1-9, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Shandong New Time Pharmaceutical Co., Ltd., a manufacturer of parenteral, tablet, non-sterile liquid, and API drugs in Linyi, China. The document outlines significant observations regarding the company’s compliance with regulatory standards for drug manufacturing.

The primary issues observed concerned the absence of adequate procedures to prevent microbiological contamination in sterile drug products. Specific findings included the routine shutdown of HEPA air filtration systems in aseptic areas without proper risk assessment or requalification involving media fills. Inspectors also noted inadequate aseptic transfer methods for sterilized equipment into Restricted Access Barrier Systems (RABS), deficiencies in smoke studies, and unacceptable operator practices that could compromise sterility. Furthermore, environmental monitoring was found lacking, with insufficient viable air and surface sampling within RABS, and growth media plates without necessary neutralizing agents for disinfectants.

A second major observation highlighted inadequate procedures for monitoring and validating manufacturing processes to control variability. This involved the failure to fully establish operating ranges for critical physical process parameters during validation, such as for specific manufacturing processes, and insufficient point-of-use sampling for critical materials like water used in formulations.

These observations signify potential non-compliance with current Good Manufacturing Practices (GMP). Shandong New Time Pharmaceutical Co., Ltd. is required to provide a comprehensive response detailing corrective actions to address each observation, ensuring the quality, safety, and efficacy of their drug products.