# China NMPA Drug Inspection - Shanxi Jinhua Huixing Pharmaceutical Co., Ltd. - Levofloxacin Hydrochloride Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-jinhua-huixing-pharmaceutical-co-ltd/27448d9a-5722-485a-9ca8-3d87a86acaf6/
Source feed: China

> China NMPA drug inspection for Shanxi Jinhua Huixing Pharmaceutical Co., Ltd. published October 22, 2010. Drug: Levofloxacin Hydrochloride Tablets. The State Food and Drug Administration (SFDA) of China, under its national drug sampling inspection work plan, issued th

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: National Drug Quality Bulletin (Issue 3, 2010, Serial No. 83)
- Company Name: Shanxi Jinhua Huixing Pharmaceutical Co., Ltd.
- Publication Date: 2010-10-22
- Drug Name: Levofloxacin Hydrochloride Tablets
- Inspection Finding: Content determination did not meet the standard requirements
- Summary: The State Food and Drug Administration (SFDA) of China, under its national drug sampling inspection work plan, issued the National Drug Quality Bulletin (No. 83) on October 22, 2010. This bulletin outlined findings from a nationwide quality inspection covering 24 drug varieties, including 9 essential medicines. The inspection analyzed 5181 product batches, primarily manufactured between 2007 and 2009. While 5142 batches met standards, 39 batches were non-compliant, indicating an overall good product quality. Key issues involved multiple companies: Beihai Sunshine Pharmaceutical Co., Ltd. had dissolution issues with Promethazine Hydrochloride Tablets. Beijing Yimin Pharmaceutical Co., Ltd.'s Nitroglycerin Tablets failed content uniformity and content determination. Shanxi Jinhua Huixing Pharmaceutical Co., Ltd.'s Levofloxacin Hydrochloride Tablets had content determination deficiencies. Beijing Taiyang Pharmaceutical Co., Ltd. faced dissolution problems with Cephalexin Tablets. Lastly, Wuhan Wujing Pharmaceutical Co., Ltd.'s Ciprofloxacin Hydrochloride Eye Drops contained visible foreign matter. The bulletin aims to enhance drug supervision and public safety, but specific enforcement actions against the non-compliant companies were not detailed in this announcement.

Company: https://www.globalkeysolutions.net/companies/shanxi-jinhua-huixing-pharmaceutical-co-ltd/9ab67280-45f5-468a-8d0e-fd9c4f55c337/