# China NMPA Drug Inspection - Guilin Changsheng Pharmaceutical Co., Ltd. - Norfloxacin capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guilin-changsheng-pharmaceutical-co-ltd/0386a6d8-f0b0-442a-93b5-26f628f9943f/
Source feed: China

> China NMPA drug inspection for Guilin Changsheng Pharmaceutical Co., Ltd. published April 19, 2017. Drug: Norfloxacin capsules. The Shandong Provincial Food and Drug Administration (NMPA) announced the results of comprehensive drug quality supervis

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shandong Province Drug Quality Bulletin, 2017, Issue 2
- Company Name: Guilin Changsheng Pharmaceutical Co., Ltd.
- Publication Date: 2017-04-19
- Drug Name: Norfloxacin capsules
- Inspection Finding: Check - Dissolution
- Action Taken: The relevant municipal food and drug administration bureaus have taken control measures such as sealing, seizing, suspending sales, and recalling the substandard drugs found in the sampling inspections, and have investigated and dealt with the manufacturers and sampled units in accordance with relevant laws and regulations.
- Summary: The Shandong Provincial Food and Drug Administration (NMPA) announced the results of comprehensive drug quality supervision and sampling inspections conducted between November and December 2016. These inspections targeted drug production and distribution enterprises, as well as medical institutions throughout the province.

Operating under the regulatory framework of the Chinese Pharmacopoeia (2010 and 2015 editions) and the Shandong Province Traditional Chinese Medicine Pieces Processing Standards (2012 edition), the inspections revealed significant non-compliance. Multiple manufacturers and sampled units, including Anhui Bozhou Sanzhen, Anhui Mengshi, Bozhou Shuzhong, Shandong Renhetang Pharmaceutical, and Jilin Changheng Pharmaceutical, were implicated.

Main violations centered on the sale of counterfeit drugs and numerous instances of products failing to meet quality standards. Specific issues included inaccurate content determination for active ingredients in various traditional Chinese medicines (e.g., Fried Cassia Seed, Fructus Aurantii Immaturus), non-compliance with physical properties like total ash, acid-insoluble ash, and moisture content (e.g., Earthworm, Dioscorea opposita). Additionally, Western medicines such as Norfloxacin Capsules exhibited dissolution problems, and Metoprolol Tartrate Extended-Release Tablets failed general inspection.

In response, municipal food and drug administration bureaus implemented immediate control measures. These included sealing, seizing, suspending sales, and recalling the substandard and counterfeit drugs. Furthermore, investigations and punitive actions against the implicated manufacturers and sampled units were initiated in accordance with relevant laws and regulations to safeguard public medication safety and ensure adherence to drug quality standards.

Company: https://www.globalkeysolutions.net/companies/guilin-changsheng-pharmaceutical-co-ltd/f8972083-44e4-4e2e-bd32-c287fadc1b3b/