# China NMPA Inspection - Hubei Nuodesheng Pharmaceutical Co., Ltd. - December 08, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-nuodesheng-pharmaceutical-co-ltd/285ff05c-3d8d-490f-a18f-4cd5115ba3f6/
Source feed: China

> China NMPA unannounced inspection for Hubei Nuodesheng Pharmaceutical Co., Ltd. published December 08, 2016. An unannounced inspection of Hubei Nuodesheng Pharmaceutical Co., Ltd. conducted by the State Food and Drug Administration and Hubei Provincial Food a

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Nuodesheng Pharmaceutical Co., Ltd.
- Company Name: Hubei Nuodesheng Pharmaceutical Co., Ltd.
- Publication Date: 2016-12-08
- Product Type: Drugs
- Summary: An unannounced inspection of Hubei Nuodesheng Pharmaceutical Co., Ltd. conducted by the State Food and Drug Administration and Hubei Provincial Food and Drug Administration on November 4-5, 2016, revealed multiple serious regulatory violations. The company was found to have engaged in suspected alteration and fabrication of original inspection records, specifically concerning hesperidin content tests for Agarwood Qi-Regulating Pills, where injection times were altered. Furthermore, the company failed to fully implement required supplementary testing methods for agarwood materials, omitting physicochemical identification. Critical issues included the on-site detection of arisin acid in several batches of Agarwood Qi-Regulating Pills, strongly suggesting the illegal addition of unauthorized substances. Significant data integrity problems were identified, as the warehouse keeper deleted finished product entry and exit data from the computer system. Reconciled data revealed inconsistencies between recorded production and actual warehouse inventory for specific pill batches, with inventory numbers exceeding production records. Discrepancies were also noted in medicinal materials warehouse inventory records for agarwood. Additionally, the company failed to conduct mandatory aflatoxin testing for certain raw materials like tangerine peel and malt, violating Chinese Pharmacopoeia standards. These actions violated the "Drug Administration Law of the People's Republic of China" and Good Manufacturing Practice (GMP) regulations. Consequently, the Hubei Provincial Food and Drug Administration revoked the company's Drug GMP Certificate. Required actions include supervising the sealing of all agarwood-containing pill inventory, ordering the recall of all affected sold products, and initiating a comprehensive investigation into the company's illegal production activities.

Company: https://www.globalkeysolutions.net/companies/hubei-nuodesheng-pharmaceutical-co-ltd/ee527245-cf48-4312-9e29-32f7e04bc836/