# China NMPA Inspection - North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd. - March 29, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/north-china-pharmaceutical-group-xiantai-pharmaceutical-co-ltd/6a6fe210-fb0e-4a9f-bfb1-47cb62e0942f/
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> China NMPA unannounced inspection for North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd. published March 29, 2016. An unannounced inspection of North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd., conducted from December 16-18, 2015, revealed signific

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd.
- Company Name: North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd.
- Publication Date: 2016-03-29
- Product Type: Drugs
- Summary: An unannounced inspection of North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd., conducted from December 16-18, 2015, revealed significant non-compliance with drug manufacturing regulations. Key violations included widespread issues with materials and product management, where large quantities of unlabeled materials were stored without proper documentation, and qualified and unqualified products lacked clear segregation. Validation and verification processes were found deficient, specifically regarding the procaine penicillin manufacturing process. There was no validation for mixing uniformity, and a critical discrepancy existed between the validated mixing time and the approved process specifications and actual production records. Furthermore, the company's product quality review and analysis procedures were inadequate. Inconsistent data for residual solvents were noted between annual audit reports and deviation investigations, with insufficient follow-up on identified quality issues. Document management was also a major concern; several critical operational documents, including supplier lists, inspection records, and production orders, were not properly controlled, approved, or maintained. The company's submitted rectification report was deemed insufficient, as it failed to address root causes or implement effective preventative measures for the identified deficiencies. Consequently, these actions violated the Drug Administration Law and Good Manufacturing Practice (GMP) regulations. As a result, the Hebei Provincial Food and Drug Administration revoked the company's GMP certificate. The State Food and Drug Administration has mandated continued supervision by the Hebei FDA to assess product risks and initiate further investigations and risk control measures as necessary.

Company: https://www.globalkeysolutions.net/companies/north-china-pharmaceutical-group-xiantai-pharmaceutical-co-ltd/04dcfc14-9e25-4a0c-ad35-e8ddf0fc0f0c/