China NMPA Inspection - Zhengzhou Lehman Pharmaceutical Co., Ltd. - May 15, 2018

An unannounced inspection of Zhengzhou Lehman Pharmaceutical Co., Ltd. was conducted on April 26, 2018, by the National Food and Drug Administration and the Henan Provincial Food and Drug Administration. The inspection, based on the "Key Points for Cosmetic Production License Inspection," identified one serious defect and seven general deficiencies in the company's operations. The serious violation involved an unreasonable workshop layout for children's skincare product production, specifically a single changing room preventing proper clean area access. General defects included the absence of effective finished product inspection standards and deficiencies in quality management system documentation, such as missing pagination and inadequate control of obsolete documents. The company also failed to conduct regular internal audits in 2016 and 2017. Issues in material and product management comprised missing batch inspection reports for key raw materials like eucalyptus oil and methyl salicylate, and raw material labels in the warehouse lacking supplier information. Furthermore, the sample retention room lacked essential temperature and humidity control, compromising the storage conditions for retained product samples. Production management problems included inconsistencies in raw material names on production records and missing batch and packaging material numbers for Lehman Chapped Skin Cream. As a result of these findings, the Henan Provincial Food and Drug Administration is mandated to order Zhengzhou Lehman Pharmaceutical Co., Ltd. to rectify all identified issues within a specified timeframe. Following the company's remediation, the provincial administration must report the resolution to the Drug and Chemical Supervision Department of the State Drug Administration.