# China NMPA Drug Inspection - Hebei Hehuachi Pharmaceutical Co., Ltd. - Lovastatin capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hebei-hehuachi-pharmaceutical-co-ltd/fa0f3ec7-cb88-45ad-8c56-c5af6e5b38cc/
Source feed: China

> China NMPA drug inspection for Hebei Hehuachi Pharmaceutical Co., Ltd. published November 09, 2009. Drug: Lovastatin capsules. On November 9, 2009, China's State Food and Drug Administration (SFDA) published its National Drug Quality Bulletin, det

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: National Drug Quality Bulletin (Issue 3, 2009, No. 79)
- Company Name: Hebei Hehuachi Pharmaceutical Co., Ltd.
- Publication Date: 2009-11-09
- Drug Name: Lovastatin capsules
- Inspection Finding: The test result (dissolution rate) is not up to standard.
- Action Taken: Investigate and punish according to law
- Summary: On November 9, 2009, China's State Food and Drug Administration (SFDA) published its National Drug Quality Bulletin, detailing results from its 2009 national evaluation and sampling plan. The inspection focused on seven pharmaceutical preparations, including clindamycin, lovastatin, antiviral drugs, tobramycin, bismuth potassium citrate, and cimetidine. While the overall quality of most sampled drugs was found to be good, issues were identified with Lovastatin preparations. Specifically, Livzon Pharmaceutical Group Xinbeijiang Pharmaceutical Co., Ltd. had two batches (0804005A) of Lovastatin Tablets that failed the dissolution test. Similarly, Hebei Huajia Pharmaceutical Co., Ltd. had two batches (20080601 and 20080101) of Lovastatin Capsules also fail the dissolution test. These failures indicate that the drugs may not release their active ingredient effectively within the body. Under the regulatory framework, provincial food and drug administration departments were mandated to investigate and address these substandard drug findings and the involved companies. They were required to report their findings to the SFDA's Inspection Bureau by the end of November 2009, with a copy to the Drug Market Supervision Office. This action aims to ensure public drug safety and uphold quality standards.

Company: https://www.globalkeysolutions.net/companies/hebei-hehuachi-pharmaceutical-co-ltd/35eb8be6-bd17-41da-b9bd-ae3b426a9229/