# China NMPA Drug Inspection - Qufu Pharmaceutical Excipients Co., Ltd. - microcrystalline cellulose

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/qufu-pharmaceutical-excipients-co-ltd/0190850e-089f-45db-9a72-46e24844e059/
Source feed: China

> China NMPA drug inspection for Qufu Pharmaceutical Excipients Co., Ltd. published December 16, 2019. Drug: microcrystalline cellulose. The Henan Provincial Drug Administration conducted a specialized supervision and sampling inspection of pharmaceutical e

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Henan Provincial Drug Administration Regarding Four Batches of Substandard Pharmaceutical Excipients and Packaging Materials (Issue No. 12, 2019)
- Company Name: Qufu Pharmaceutical Excipients Co., Ltd.
- Publication Date: 2019-12-16
- Drug Name: microcrystalline cellulose
- Inspection Finding: The inspection (residue on ignition) did not meet the requirements.
- Action Taken: Relevant drug regulatory authorities have taken control measures on the products and investigated and dealt with them in accordance with the law, requiring enterprises to take control measures such as suspending sales, use or recalling products according to the level of risk, and to find out the reasons for non-compliance and eliminate potential risks.
- Summary: The Henan Provincial Drug Administration conducted a specialized supervision and sampling inspection of pharmaceutical excipients and drug packaging materials in 2019, with findings announced on December 16, 2019. The inspection involved 300 batches across various manufacturers in the province. Out of these, 296 batches were deemed compliant, resulting in a 98.7% pass rate, while four batches were identified as non-compliant.Key violations included: Changge Bairu Pharmaceutical Materials Co., Ltd. for corn starch (batch 1802041) failing 'Appearance' criteria based on Chinese Pharmacopoeia 2015 Edition; Qufu Pharmaceutical Excipients Co., Ltd. for microcrystalline cellulose (batch 20180901) failing 'Residue on Ignition' according to Chinese Pharmacopoeia 2015 Edition; and Henan Huabao Glass Co., Ltd. for two batches (181216 and 181016) of low borosilicate glass ampoules, which failed 'Breaking Force' requirements as per standard YBB00332002-2015.The regulatory framework for these inspections is the Henan Provincial Drug Administration, which enforces national pharmacopoeia and industry standards for pharmaceutical quality. In response to these findings, the administration has mandated that relevant regulatory departments take control measures and conduct thorough investigations. The affected companies are required to implement immediate corrective actions, including suspending sales and usage, recalling products where necessary based on risk assessment, investigating the root causes of non-compliance, and actively mitigating any potential risks to ensure product safety and quality.

Company: https://www.globalkeysolutions.net/companies/qufu-pharmaceutical-excipients-co-ltd/6092be2c-9344-4dd4-86e1-2769da345cf5/