China NMPA Inspection - Shaanxi Renkang Pharmaceutical Co., Ltd. - December 13, 2018

During an unannounced inspection on November 6-7, 2018, Shaanxi Renkang Pharmaceutical Co., Ltd., a manufacturer of Contact Lens Care Solution, was found to be non-compliant with the Good Manufacturing Practice for Medical Devices and its sterile medical device appendix. Several issues were identified across key operational areas.

Deficiencies included poor document control, where updated quality standards for raw materials lacked proper cancellation marks. Supply chain management was also cited, as quality agreements with primary packaging material suppliers did not specify acceptable microbial and particulate contamination levels. Production records were incomplete, with raw material batch numbers not consistently recorded. Operational control weaknesses involved the absence of established procedures for replacing hand sanitizer varieties. Significant inconsistencies were noted in batch numbering practices; specifically, multiple products produced on different dates shared the same research and development batch numbers, and the company lacked defined requirements for managing these R&D batch numbers. Lastly, actual retention quantities for product samples were less than the minimum required by the company's own procedures.

As a direct consequence, Shaanxi Renkang Pharmaceutical Co., Ltd. was instructed to cease all production activities. The company is prohibited from resuming manufacturing until it successfully undergoes and passes a re-inspection by the Shaanxi Provincial Drug Administration, demonstrating full compliance with regulatory standards.