# China NMPA Drug Inspection - Shanghai Huayi Group Huayuan Chemical Co., Ltd. - Solid pharmaceutical-grade polyethylene bottled silica gel desiccant

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-huayi-group-huayuan-chemical-co-ltd/edd9c40d-a37b-49cd-94dc-20c4bc51ce5a/
Source feed: China

> China NMPA drug inspection for Shanghai Huayi Group Huayuan Chemical Co., Ltd. published April 09, 2018. Drug: Solid pharmaceutical-grade polyethylene bottled silica gel desiccant. The Shanghai Municipal Food and Drug Administration (SFDA) issued an announcement on April 9, 2018, detailing the result

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shanghai Municipal Food and Drug Administration's Third Announcement on Drug Supervision and Sampling Quality in 2018 (April 9, 2018)
- Company Name: Shanghai Huayi Group Huayuan Chemical Co., Ltd.
- Publication Date: 2018-04-09
- Drug Name: Solid pharmaceutical-grade polyethylene bottled silica gel desiccant
- Inspection Finding: Moisture absorption rate not up to standard
- Action Taken: The Shanghai Municipal Food and Drug Administration has investigated and punished the illegal activities of the companies involved in producing and selling substandard products, and has required them to take risk control measures such as suspending sales, use, and recalling the products. At the same time, it will strengthen follow-up inspections and random checks, and urge companies to find out the cause and implement rectification.
- Summary: The Shanghai Municipal Food and Drug Administration (SFDA) issued an announcement on April 9, 2018, detailing the results of its 2018 drug supervision and sampling inspections. These inspections targeted various drug and pharmaceutical packaging material manufacturers, distributors, and users, covering products from 2017 batches. Several companies were cited for non-compliance, including Suzhou Boyuan Pharmaceutical Co., Ltd., Shanghai Huayuan Pharmaceutical Co., Ltd., Shanghai First People's Hospital, Suzhou Chunhuitang Pharmaceutical Co., Ltd., and Shanghai Huayi Group Huayuan Chemical Co., Ltd. Main violations included "Content Determination" issues for Polygonum multiflorum and Fennel Seeds, indicating active ingredient levels did not meet standards. "Sulfur Dioxide Residue" exceeded limits in Glehnia littoralis, while "Content Difference" was noted in Clodisongol Cream, suggesting inconsistent active ingredient distribution. Additionally, "Moisture Absorption Rate" for solid pharmaceutical desiccant was found deficient. These findings were based on established regulatory frameworks, including the 2015 Edition of the Chinese Pharmacopoeia and Shanghai's specific processing regulations and quality standards. As a result, the SFDA mandated immediate risk control actions for the implicated companies. These actions included suspending sales and use, and recalling the substandard products. Furthermore, companies are required to investigate the root causes of non-compliance, develop and implement corrective action plans, and eliminate potential future risks. The SFDA also committed to intensified follow-up inspections and ongoing supervision to ensure compliance and market safety.

Company: https://www.globalkeysolutions.net/companies/shanghai-huayi-group-huayuan-chemical-co-ltd/ff7ace04-521d-4a55-86cf-bb57a04acfc2/