# China NMPA Inspection - Shangqiu Jinma Pharmaceutical Co., Ltd. - March 03, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shangqiu-jinma-pharmaceutical-co-ltd/525326a5-cb88-4c61-b955-f08b0ba83449/
Source feed: China

> China NMPA unannounced inspection for Shangqiu Jinma Pharmaceutical Co., Ltd. published March 03, 2017. An unannounced inspection of Shangqiu Jinma Pharmaceutical Co., Ltd., conducted from January 13-15, 2017, revealed significant non-compliance with dru

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shangqiu Jinma Pharmaceutical Co., Ltd.
- Company Name: Shangqiu Jinma Pharmaceutical Co., Ltd.
- Publication Date: 2017-03-03
- Product Type: Drugs
- Summary: An unannounced inspection of Shangqiu Jinma Pharmaceutical Co., Ltd., conducted from January 13-15, 2017, revealed significant non-compliance with drug production regulations. The primary issue involved the suspected unauthorized addition of gardenia powder to semi-finished Qingre Jiedu Tablets, contrary to the 2015 Chinese Pharmacopoeia requirements for decoction and extraction, solely to meet geniposide content standards. Furthermore, the inspection identified suspected fabrication and severe deficiencies in material record-keeping. There were no traceability records for the gardenia powder's receipt, processing, or usage. Inconsistencies were found across two material ledgers for the same batch of intermediate products, exhibiting conflicting delivery, quantity, and recipient details. Beyond these critical findings, the facility exhibited chaotic record management, with production records stored improperly and finished product release slips missing. Production areas were disorganized, featuring abandoned equipment, unprompted waste accumulation, flooded floors, moldy walls, and inadequate pest control in critical operating rooms. These actions violate the "Drug Administration Law of the People's Republic of China" and pertinent Good Manufacturing Practice (GMP) regulations. Consequently, the State Food and Drug Administration has directed the revocation of Shangqiu Jinma Pharmaceutical Co., Ltd.'s GMP certificate for tablets. The company is also mandated to implement immediate risk control measures for all related products currently on the market, while a comprehensive investigation into its suspected illegal production activities proceeds.

Company: https://www.globalkeysolutions.net/companies/shangqiu-jinma-pharmaceutical-co-ltd/09164103-f1e9-49f4-b7e6-ac686e466a75/