# China NMPA Drug Inspection - Shandong Xinhua Pharmaceutical Co., Ltd. - Lidocaine Hydrochloride Injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-xinhua-pharmaceutical-co-ltd/4cc098ad-833f-42b2-959b-5f53eb422b0e/
Source feed: China

> China NMPA drug inspection for Shandong Xinhua Pharmaceutical Co., Ltd. published February 06, 2018. Drug: Lidocaine Hydrochloride Injection. The Guangxi Zhuang Autonomous Region Food and Drug Administration (GXFDA) issued its First Drug Quality Announcement of 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin of Guangxi Zhuang Autonomous Region Food and Drug Administration (Issue 1, 2018)
- Company Name: Shandong Xinhua Pharmaceutical Co., Ltd.
- Publication Date: 2018-02-06
- Drug Name: Lidocaine Hydrochloride Injection
- Inspection Finding: [Check] Osmotic pressure molar concentration
- Action Taken: The relevant food and drug administration authorities have been organized to take necessary control measures such as sealing up, seizing, and suspending the sale of drugs that do not meet the standards, and to investigate and punish the units from which the samples were sourced in accordance with the law.
- Summary: The Guangxi Zhuang Autonomous Region Food and Drug Administration (GXFDA) issued its First Drug Quality Announcement of 2018 on February 6, 2018. This announcement followed a comprehensive drug quality sampling plan involving inspections of various drug production and distribution enterprises and medical institutions within its jurisdiction. The inspections revealed 23 batches of non-compliant drugs, comprising 7 batches of drug preparations and 16 batches of traditional Chinese medicine decoction pieces. Key violations for preparations included failures in content determination, incorrect ethanol content, and appearance defects. For traditional Chinese medicine decoction pieces, issues included excessive moisture, abnormal total ash content, non-compliant physical properties, and deviations from specifications for active ingredients or residual substances like sulfur dioxide. These findings indicate non-adherence to quality standards outlined in the Chinese Pharmacopoeia (2015 Edition) and specific Guangxi regional processing and quality standards. In response, the GXFDA has implemented control measures such as sealing, seizing, and suspending the sale of all non-compliant drugs. Additionally, the Administration is investigating and will apply legal penalties to the responsible manufacturers and distributors, underscoring its commitment to public medication safety.

Company: https://www.globalkeysolutions.net/companies/shandong-xinhua-pharmaceutical-co-ltd/acea3619-5739-4a9f-a4b2-82e0207194b3/