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

The FDA inspected Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. from May 15-19, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The firm's quality unit approved multiple lots of an OTC drug product labeled with hydrocortisone but containing dexamethasone acetate, due to a claimed "translation mistake." While a recall occurred, the firm failed to provide a detailed investigation or recurrence prevention plan. 2. **Failure to Test Drug Products (21 CFR 211.165(a)):** The firm did not test drug products for identity and strength of active ingredients prior to release. 3. **Inadequate Production and Process Control Procedures (21 CFR 211.100(a)):** The firm lacked validated manufacturing processes, process performance qualification studies, and an ongoing program for monitoring process control.

The firm's August 16, 2017, response was deemed inadequate, lacking details on quality control test methods, commitment to comprehensive testing, and timelines for process validation. The FDA strongly recommended engaging a qualified CGMP consultant.

Additionally, the firm manufactures and distributes "Piyanping Anti-Itch Lotion," which is an unapproved new drug and misbranded. It is labeled