# China NMPA Inspection - Hunan Baoling Biopharmaceutical Co., Ltd. - June 14, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-baoling-biopharmaceutical-co-ltd/7f4a892e-3227-4393-b09c-d2c436795406/
Source feed: China

> China NMPA unannounced inspection for Hunan Baoling Biopharmaceutical Co., Ltd. published June 14, 2019. On May 28, 2019, Hunan Baoling Biopharmaceutical Co., Ltd. underwent a supervision inspection based on relevant cosmetic manufacturing regulations. Th

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hunan Baoling Biopharmaceutical Co., Ltd. (2019001)
- Company Name: Hunan Baoling Biopharmaceutical Co., Ltd.
- Publication Date: 2019-06-14
- Product Type: Cosmetics
- Summary: On May 28, 2019, Hunan Baoling Biopharmaceutical Co., Ltd. underwent a supervision inspection based on relevant cosmetic manufacturing regulations. The inspection revealed multiple significant deficiencies impacting product quality and safety. Key personnel-related issues included incomplete employee files, a Quality Manager lacking the required experience and holding dual roles, and inadequate training records. Production documentation was found to be severely lacking, with batch records for several products failing to detail critical processes like cooling, aging, and filling. Quality control also presented gaps, as no commissioning agreements were available for outsourced testing, and the company's internal reports did not reflect comprehensive testing for contaminants. Further concerns involved the absence of an internal audit plan and an improperly divided production workshop without an an environmental monitoring plan. Hazardous raw materials were not appropriately managed, and equipment cleaning records were incomplete. Critically, raw material traceability for paraffin and peppermint oil was compromised due to untraceable procurement documents and missing supplier verifications. The company also failed to retain cosmetic samples in its designated sample retention room. In response to these violations of cosmetic production licensing standards, the Hunan Provincial Drug Administration issued a rectification order. Hunan Baoling Biopharmaceutical Co., Ltd. is required to address all identified issues within a specified period and submit a comprehensive rectification report.

Company: https://www.globalkeysolutions.net/companies/hunan-baoling-biopharmaceutical-co-ltd/7b37e9ce-916a-4dd0-8dd1-c97f74964dab/