# China NMPA Inspection - Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd. - August 31, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hengtuo-group-nanning-rensheng-pharmaceutical-co-ltd/0fb2dd09-b8f2-48ed-aad2-06ecc2020944/
Source feed: China

> China NMPA unannounced inspection for Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd. published August 31, 2017. An unannounced inspection of Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd. was conducted from July 4-6, 2017. This inspection, carried out b

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd.
- Company Name: Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd.
- Publication Date: 2017-08-31
- Product Type: Drugs
- Summary: An unannounced inspection of Hengtuo Group Nanning Rensheng Pharmaceutical Co., Ltd. was conducted from July 4-6, 2017. This inspection, carried out by the State Food and Drug Administration's Verification Center, revealed significant deviations from the *Good Manufacturing Practice for Pharmaceuticals* (2010 Revision). Key issues included an inconsistency between the actual production process for Compound Platycodon and Ephedrine Syrup (II) and its registered process, specifically the removal of an autoclaving step and altered ingredient addition. Data integrity was compromised by improperly configured login permissions and disabled audit trails on critical laboratory instruments such as HPLC and FTIR, with evidence of modified timestamps and non-chronological log entries. Furthermore, the company failed to conduct a systematic investigation into product non-compliance, prematurely attributing quality issues solely to raw material supplier stability. Lastly, there were discrepancies between the registered and actual raw material suppliers for several key ingredients, including ephedrine hydrochloride and platycodon root. As a result of these findings, the regulatory authority instructed the revocation of the company's GMP certificate and mandated a comprehensive investigation and evaluation of all outgoing products, with potential risk control measures such as product recalls to be implemented as necessary.

Company: https://www.globalkeysolutions.net/companies/hengtuo-group-nanning-rensheng-pharmaceutical-co-ltd/06e02c0b-1148-4d13-99b6-f80eed665783/