# China NMPA Inspection - Hubei Green Gold Pharmaceutical Co., Ltd. - January 18, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-green-gold-pharmaceutical-co-ltd/4c64aad3-d83c-476b-bb3f-31f2f3771a0d/
Source feed: China

> China NMPA unannounced inspection for Hubei Green Gold Pharmaceutical Co., Ltd. published January 18, 2019. Hubei Lvjinzi Pharmaceutical Co., Ltd. was subjected to an unannounced inspection from July 16-19, 2018, which uncovered extensive non-compliance with

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of the Results of the Surprise Inspection and Handling of Hubei Green Gold Pharmaceutical Co., Ltd.
- Company Name: Hubei Green Gold Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-18
- Product Type: Drugs
- Summary: Hubei Lvjinzi Pharmaceutical Co., Ltd. was subjected to an unannounced inspection from July 16-19, 2018, which uncovered extensive non-compliance with pharmaceutical manufacturing regulations. Key violations identified included significant failures within the quality management department, such as neglecting routine product quality reviews since June 2015, not investigating out-of-specification data, and inadequately handling production deviations and process inconsistencies. Furthermore, essential stability testing was omitted for products linked to a production address change. The QC laboratory exhibited critical deficiencies, including incomplete analytical documentation, missing reports for outsourced tests, and compromised data integrity due to unlocked computer systems for analytical equipment. Batch production records were found to be incomplete and inaccurate, failing to reflect actual manufacturing processes or material usage. Material management issues included the improper storage of expired or temperature-sensitive products and deficient inventory records. Lastly, product validation processes were deemed inadequate, lacking proper sampling, testing, and supporting data for process changes and product uniformity. These systemic failures violated the *Good Manufacturing Practice for Pharmaceuticals* (revised in 2010). Consequently, Hubei Lvjinzi Pharmaceutical Co., Ltd. ceased all production in July 2018. The regulatory authority mandated a product recall and revoked the company's GMP certificates.

Company: https://www.globalkeysolutions.net/companies/hubei-green-gold-pharmaceutical-co-ltd/f0cf218a-1c83-4f77-9c71-d53340871026/