# China NMPA Drug Inspection - Haikou Qili Pharmaceutical Co., Ltd. - Azithromycin granules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/haikou-qili-pharmaceutical-co-ltd/58ec0754-57fb-4b19-9446-426f28bac2c0/
Source feed: China

> China NMPA drug inspection for Haikou Qili Pharmaceutical Co., Ltd. published December 21, 2017. Drug: Azithromycin granules. The Shandong Provincial Food and Drug Administration issued an announcement on December 20, 2017, reporting findings fro

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Shandong Provincial Food and Drug Administration Regarding 6 Batches of Substandard Drugs in Quality Spot Checks (Issue No. 10, 2017)
- Company Name: Haikou Qili Pharmaceutical Co., Ltd.
- Publication Date: 2017-12-21
- Drug Name: Azithromycin granules
- Inspection Finding: The quality of the medicine did not meet the standard requirements; the non-compliant items were the characteristic chromatogram and the inspection items.
- Action Taken: The relevant municipal food and drug administrations have taken control measures such as sealing off, seizing, suspending sales, and recalling products, and have filed cases against the relevant manufacturers and sampled units in accordance with the law. The relevant municipal food and drug administrations should strengthen supervision, urge enterprises to investigate the causes of the problems, formulate and implement rectification measures, and effectively eliminate potential risks.
- Summary: The Shandong Provincial Food and Drug Administration issued an announcement on December 20, 2017, reporting findings from quality sampling inspections. Six batches of drugs from six manufacturers were found to be substandard. The implicated companies include Shijiazhuang Northern Pharmaceutical Co., Ltd., Furen Pharmaceutical Group Co., Ltd., Jiangsu Dahongying Hengshun Pharmaceutical Co., Ltd., Haikou Qili Pharmaceutical Co., Ltd., Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Hejigong Pharmaceutical Factory, and Suzhou Yushi Pharmaceutical Co., Ltd.The main violations centered on the failure of these drug products to meet established quality standards, specifically regarding characteristic chromatograms and other critical inspection items. This indicates a deviation from their approved quality specifications.Under the provincial regulatory framework for drug quality supervision, authorities have taken immediate and stringent actions. These include sealing, seizing, suspending sales, and recalling the substandard drugs. Additionally, investigations and legal prosecutions have been initiated against the implicated manufacturers and sampled units. The municipal food and drug administrations are required to enhance oversight of these products and enterprises, ensuring they identify the root causes of the deficiencies, formulate and implement effective rectification measures, and eliminate potential risks to public health.

Company: https://www.globalkeysolutions.net/companies/haikou-qili-pharmaceutical-co-ltd/69d5da15-aace-411c-9e46-6096a4b9cd85/