# China NMPA Drug Inspection - Shaanxi Huayuan Pharmaceutical Co., Ltd. - Pediatric antipyretic oral liquid

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shaanxi-huayuan-pharmaceutical-co-ltd/687b7c42-980b-4bc4-be8f-42b6efce7945/
Source feed: China

> China NMPA drug inspection for Shaanxi Huayuan Pharmaceutical Co., Ltd. published November 25, 2016. Drug: Pediatric antipyretic oral liquid. The State Food and Drug Administration (SFDA) of China, on November 25, 2016, announced the findings of national drug sa

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 156 of 2016 from the State Administration for Market Regulation regarding 29 batches of substandard drugs from 25 companies including Korla Longzhiyuan Pharmaceutical Co., Ltd.
- Company Name: Shaanxi Huayuan Pharmaceutical Co., Ltd.
- Publication Date: 2016-11-25
- Drug Name: Pediatric antipyretic oral liquid
- Inspection Finding: The product was found to be substandard after inspection. The substandard items included appearance, identification, content determination, and, under the inspection items, fill weight variation, weight variation, dissolution rate, solubility, bacterial count, acidity, color enhancement effect, moisture content, dispersibility time, loss on drying, and microbial limits.
- Action Taken: The company was ordered to suspend production and sales and recall products; it was to be investigated and dealt with in accordance with the provisions of the "Drug Administration Law of the People's Republic of China" and other relevant regulations; and it was ordered to thoroughly investigate the causes of the drug quality problems and take targeted measures to rectify them.
- Summary: The State Food and Drug Administration (SFDA) of China, on November 25, 2016, announced the findings of national drug sampling inspections, revealing 29 batches of substandard drugs from 25 pharmaceutical enterprises. Noteworthy companies implicated include Korla Longzhiyuan Pharmaceutical Co., Ltd. and Henan Kanghua Huaiqing Pharmaceutical Co., Ltd. The inspections uncovered a range of quality control deficiencies across various drug products. Violations encompassed critical aspects such as appearance, identification, content determination, and pharmaceutical properties like fill weight variation, dissolution rate, bacterial count, and microbial limits.

Operating under the regulatory framework of the 'Drug Administration Law of the People's Republic of China,' provincial food and drug administrations were instructed to implement immediate measures. These actions included ordering the affected companies to suspend production, halt sales, and recall the non-compliant products. Furthermore, enterprises are mandated to conduct thorough investigations into the root causes of these quality issues and implement targeted corrective actions. The SFDA also stipulated that legal proceedings should be initiated against the non-compliant companies, and all relevant information, including corrective actions, must be publicly disclosed to ensure industry transparency and accountability.

Company: https://www.globalkeysolutions.net/companies/shaanxi-huayuan-pharmaceutical-co-ltd/7de8a380-2ca9-4ce2-95a1-ac34c679e006/