FDA 483 - Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. - May 19, 2017

During an inspection conducted from May 15 to May 19, 2017, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd., an over-the-counter (OTC) drug manufacturer in Zhanjiang City, China. This document outlined significant observations regarding the company's adherence to regulatory manufacturing standards.

Key issues identified included critical product integrity concerns where "Piyanping 1% Hydrocortisone Lotion" was found to contain Dexamethasone instead of Hydrocortisone. The inspection also revealed a systemic failure in quality control, with no testing performed for the identity and strength of active ingredients, nor stability testing for U.S. marketed batches. Microbiological testing procedures were inadequate, lacking essential record details, proper controls, and media validation.

Furthermore, the facility exhibited deficiencies in sanitation, notably the absence of soap and hot water in critical areas. The company lacked essential written procedures for managing product recalls, investigating complaints with its distributor, and notifying the FDA of adverse events or stability failures. Equipment used in manufacturing was not qualified, and process parameters remained unvalidated. Additionally, batch production records were incomplete, missing vital operational details and test results. These observations indicate a need for comprehensive corrective actions to ensure product quality, safety, and compliance with established manufacturing regulations.